Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Smiths medical has identified that certain series 3500 medfusion syringe pumps were assembled with a barrel clamp guide containing a ridge within the component. this ridge could potentially lead to spring slippage, resulting in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe being loaded.
Action
A Smiths Medical Representative will be contacting users to arrange repair of affected devices
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Becton dickinson (bd) has identified an issue with the alaris pump module regarding increased or decreased flow rates that have occurred in pumps with mechanical assemblies manufactured between november 2011 and march 2012.The component of the alaris pump module causing this issue is the bezel assembly, specifically the bezel posts. the affected posts may have cracking in one or more posts that connect the mechanism frame to the bezel assembly. separation of one or more bezel posts may prevent the device from delivering an accurate amount of fluid through the pumping cycle, resulting in an over or under infusion.Zero reports relating to this issue have been received in australia.
Action
BD has assessed the risk of this issue and determined that the affected product can still be used until this correction is carried out. However, BD strongly recommends that clinicians increase their level of vigilance when using impacted pumps. Additionally, clinicians should remove the pump from service if it shows signs of infusion at an unexpected rate. Use non-affected, or remediated, devices in high risk areas if possible. In addition, to the best of BD’s ability, BD will work with customers to identify and mark individual pumps that have not yet been remediated.
BD will replace the mechanical assembly of the affected serial numbers at no charge. BD will be in contact with all affected customers to initiate the scheduling process for the remediation.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Smiths medical has become aware that certain non-flow-stop cadd medication cassette reservoirs may have been manufactured with an incorrect pressure plate. this product is designed without an arch, but the defective product has a plate with an arch.There is a risk that under delivery of medication may result from the tubing becoming partially or completely occluded when the cassette is attached to the pump. the clinician is not aware of the issue because the pump will continue to operate as if it is infusing medication without alarming for an occlusion.
Action
Smiths Medical is advising users to quarantine remaining stock of the affected product for return for credit. It is recommended that users transition to an equivalent flow stop version of the CADD Medication cassettes.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Fresenius kabi australia has received notice from the manufacturer, moog medical group, that they have initiated a recall in the usa for certain non-filtered moog iv administration sets manufactured between 9th june 2015 and 6th july 2016. the manufacturer received 7 complaints regarding particulate found on the tip of non-filtered moog iv spike sets manufactured between 9th june 2015 and 6th july 2016. during that period, 1,390,720 non-filtered spike administration sets were manufactured. when found, the loose particulate is located on the external edge of the non-vented spike and can potentially enter into the fluid path. introducing foreign material into the body can cause a range of side effects depending on the particle size and the type of line being used. no complaints have been received in australia to date.
Action
Fresenius Kabi is advising customers to check inventory and quarantine affected stock. Fresenius Kabi will contact affected users to arrange return of stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
During testing of the non-coring needle, cook medical have identified that the non-coring needle provided with the cook vital-port vascular assess system (vital-port) may cut or dislodge a core or sliver of material from the vital-port septum when the non-coring needle is inserted into the vital-port. this needle is used on the initial implant of the vital-port. vital-port products that have been successfully placed in patients are not impacted by this recall. there have been no adverse event reports from septum leakage or a silicone sliver pushed into the patient associated with these products to date.
Action
Cook Medical is advising users to inspect stock and quarantine any remaining units of the affected products for return.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
This action is a follow up to the july 2013 communication regarding the synchromed ii priming bolus function and to inform that medtronic is updating the model 8870 software application card as well as the synchromed infusion system labelling to address the issue. the software update will change the value displayed on the 8840 programmer for the synchromed ii pump tubing volume from 0.199 ml to 0.140 ml. over delivery of drug during priming bolus has the potential to lead to overdose symptoms in some patients. this software change mitigates the potential for unintended over-delivery of drug while still ensuring prompt therapy initiation. the synchromed ii infusion system manuals were updated for the priming bolus function, and new guidelines for priming have been implemented.
Action
Doctors are advised to continue to use the current software card and its displayed tubing volume until the Medtronic Representative has exchanged the current card with the new software card (new version is BBU01). New guidelines in labelling regarding priming bolus are identified in the customer letter and the attachment provided with the letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Imaxeon have determined that all current source administration sets (sas) used with the medrad intego pet infusion system may produce particulates in radiopharmaceutical (rp) vials when the needle is inserted. these particulates may be generated when the tip of the needle pushes through the rubber septum of the vial. this presents a potential safety risk of particulate(s) being injected into a patient. to date, there have been no reports of patient or user injury.
Action
Imaxeon is advising customers to immediately discontinue use of the Intego system and quarantine the SAS disposable units that they have in stock. They are also advised to determine an alternative method of the radiopharmaceutical delivery such as manual injections, if feasible. Imaxeon is in the process of qualifying a compatible in-line filter to be used with the SAS and will advise customers of the results in the next few weeks. Due to the limited inventory, customers may retain their quarantined units to be later used with the in-line filters. Alternatively, customers may return their units back to Imaxeon for a credit.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
This communication is an update to medtronic’s march 2014 notification regarding the potential for synchromed ii pump over-infusion. “over-infusion” is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s flow rate accuracy specification. pump reservoir contents that are less than expected may indicate that the pump has over-infused. over-infusion may or may not be associated with clinically relevant symptoms. when the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms. patients may experience under-dose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an over-infusing pump. the low reservoir alarm of an over-infusing pump will not sound if the pump reservoir is prematurely depleted. the low reservoir alarm is calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume remaining in the reservoir.
Action
Medtronic is communicating the appropriate patient management recommendations and guidelines to the clinicians managing the patients implanted with the affected devices. For more details, please see https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump . This action has been closed-out on 26/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Extra notes in the data
Reason
Icu medical has identified a potential for the connectivity engine (ce) module to disengage from the main chassis. in a rare situation, this could lead the plum 360 infuser to power down without an alarm notification resulting in a delay of either initiation of a therapy or interruption of an active infusion. in rare circumstances, these conditions could lead to serious adverse health consequences related to life threatening or permanent injury, which may include death.To date, icu medical has not received any reports of serious injury or death associated with this issue.
Action
ICU Medical will be contacting users and arranging for inspection of all affected Plum 360 infusers. The chassis will be replaced as required. In the interim, ICU Medical is advising users to inspect the affected Plum 360 Infusers using the instructions provided in the customer letter in order to verify that the infuser is working. If at the end of testing a loose CE module or blank display is observed, the infuser is to be removed from service, and the user is to record the S/N and contact the ICU Service Department. Otherwise, the infuser can be returned to clinical use. If the Plum 360 Infuser powers down without an alarm notification during infusion, use another Plum 360 Infuser for infusion or consider use of alternative infusion methods based on the clinical situation.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Roche diabetes care has identified a programming error in the accu-chek connect diabetes management app ios version 1.2.0(.5) which under certain conditions could potentially lead to an inaccurate bolus insulin advice being provided to the patients. as a result of this issue the app “lightbulb” icon is not displayed and the correction bolus advice is not available.. the blood glucose (bg) value which could not be used initially may unintentionally become available for bolus advice calculation at a later time. if the patients then request a bolus advice for a bg value older than 10 minutes without taking and transferring a new bg measurement, it could lead to an incorrect bolus insulin recommendation. depending on the actual metabolic situation a potentially incorrect bolus advice could lead to serious health consequences.
Action
Roche is advising Health Care Professionals to inform their patients by distributing a copy of the letter, to whom the Accu-Chek Connect diabetes management app has been distributed. Patients are being advised to discontinue using version 1.2.0.5 and update their app immediately to version 1.2.2.2. This action has been closed-out on 12/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Dräger has become aware of a case in which a babytherm 8004 without patient was operated in skin temperature mode with skin temperature sensor to prepare it for use. ln skin temperature mode, the radiant warmer output is controlled automatically until the set skin temperature is reached. as a result of operating the temperature sensor without patient contact, the radiant warmer was operated continuously at a high output ievel. during this forced continuous operation under high thermal ioad, the heater element aged faster. a part became detached from the heater element and fell onto the mattress tray where a towel caught fire. dräger's investigation revealed that the instructions for use do not contain explicit hints/warnings that refer to this misuse. additionally, dräger's analyses have shown that the heater elements are not replaced at regular intervals as recommended in the babytherm instructions for use.
Action
Dräger has amended the Instructions for Use Manual for new devices, and is providing users with a supplement which contains additional warnings and following additional instructions:
- Do not operate the device in skin temperature mode with temperature sensor without patient contact
- lf the heating elements have been in operation for more than 2 years, please replace them.
Customers are advised to distribute the notice to all departments with the Babytherm Infant Warmer; models 8004; and/or 8010 within their facility. This action has been closed-out on 20/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Roche diabetes care has become aware that in a limited number of cases, patients using the accu-chek spirit combo insulin pump may experience a loss of the date and time settings. investigations undertaken by roche revealed that this issue may occur if the pump capacitor fails to function properly due to a leakage. the capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change.
Action
Roche is advising end users and healthcare professionals of the potential issue. End users are advised to ensure that the time and date are set correctly after a battery change. Users who experience any failures are requested contact the Accu-Chek Customer Care Line to arrange for a replacement pump. For more details, please see http://www.tga.gov.au/safety/alerts-device-accu-chek-insulin-pump-141003.htm This action has been closed-out on 18/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Roche has become aware that some customers are experiencing an increase of mechanical errors with their insulin pumps showing e6 & e10 error messages. this is associated with handling of the cartridge during the cartridge change process. roche has improved the handling instructions for the cartridge change to prevent the future occurrence of this issue.If users do not follow the cartridge change process step-by-step as described in the updated handling instructions, there is a potential risk of small insulin amounts to drip into the cartridge compartment, and result in a damage of the piston rod over time, so that the piston rod will not properly move and potentially limit or cause a blockage of the insulin pump motor function. eventually, this may result in the insulin not being delivered as intended. the issue is easily detectable as the pump will alert the user by acoustic, visual & vibration alerts.
Action
Roche is contacting all users and providing a training leaflet with step by step instructions to assemble the cartridge, adapter and infusion set tubing first, prior to inserting the new cartridge into the insulin pump. For more details, please see http://www.tga.gov.au/alert/accu-chek-spirit-combo-and-accu-chek-spirit-insulin-pumps . This action has been closed-out on 04/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The manufacturer has received complaints in germany regarding sediment residuals in the manifold of the washer and disinfector of getinge 46-series (cm302) with pacs 300/350 control.The potential risk is that during the drying phase the air circulating may transport particles from the sedimentation and deposit it on goods. if the particle contains bacterial flora there is the risk of cross contamination.The problem has been identified as insufficient water flow throughout the manifold due to formation of air-pockets where sedimentation may occur. the use of detergents that are not recommended might also have negative impact.No serious injury has been reported in any of the known cases.
Action
Getinge will contact customers to carry out a modification that will permanently mitigate the risk of this issue occurring in the future. In the interim customers are advised to perform a visual check of all washed items after removal from the washer. Items should be re-washed if any particles are observed. This action has been closed-out on 1/06/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Some units have an off-centred slit in the silicon septum resulting in a thinner column wall. when actuated, units with a thinner column wall may tear leading to leakage of infusate/medication or blood from the side vent opening. in addition to leakage, the manufacturer has identified that there is a smallpotential risk for air to enter the bloodstream which could result in air embolism.
Action
Customers are advised to discontinue use of and immediately quarantine any of the affected stock. This action has been closed-out on 09/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
During use, the bolt in the connection between the spreader bar and the lifting arm jig is subjected to mechanical forces, which may lead to breakage. this is due to the design of the connection between spreader bar and lifting arm jig, which in long term use can cause metal fatigue in this part and the formation of micro-cracks in the thread of the bolt. this issue is only related to tenor devices without scales.
Action
ArjoHuntleigh will arrange for the replacement of the old spreader bar with a new spreader with scales. This action has been closed-out on 12/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Extra notes in the data
Reason
Through customer reports, hospira has become aware that patients or unauthorised carers have been able to locate the default keypad lock code for gemstar infusion pumps through internet searches in order to tamper with the programmed infusion parameters. hospira have received no reports relating to this issue in australia. one of the reports overseas resulted in a serious injury.
Action
Hospira is recommending users change the default keypad lock code upon receipt of the device and prior to delivery to patients, and remove the clinical instructions from the manual to prevent unauthorised access. Hospira will be providing users with an updated System Operating Manual to include the requirement to change the default keypad code.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
There is a labelling inaccuracy in the instructions for use (ifu) and injection card. the ifu and the injection card contained within the product states that picc testing included 10 pressure injection cycles. this is not correct, it should state that catheter testing included only 5 pressure injection cycles.If it were to be used for more than five (5) pressure injections, it cannot be ruled out that there is a potential risk that the catheter could rupture during injections 6-10. catheter rupture can cause catheter or air embolism, bleeding or ineffective treatment and may require the need for radiologic or surgical intervention. no customer complaints have been received for this issue.
Action
Customers are notified not to use the device for more than five pressure injections. Future stock will have the IFU and injection card amended to reflect this change. This action has been closed-out on 26/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Carefusion has received service reports of a channel error on the alaris system syringe module model 8110. a channel error is displayed on the syringe module in association with an audible and visual alarm on the attached pc unit (error code 351.6740); once cleared on the pcu the syringe module remains unresponsive to key presses. this error could occur during an infusion causing an interruption of infusion. whilst connected to an alaris system pcu at the time of error, upon power down and reattachment to any other module the pcu will continue to function as expected, there is no fault or flow on effect to the pcu module.
Action
CareFusion will adjust the syringe drive train assembly on the affected units and replace, if required. This action has been closed-out on 06/09/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Issue 1 – users could inadvertently extend the blood glucose timestamp for a given blood glucose value by 12 minutes leading to a potentially incorrect bolus dose calculation. medtronic is currently not aware of any malfunctions, complaints, adverse effects, disease, illness, injuries or confirmed deaths related to this issue; andissue 2 – the ‘max bolus exceeded’ & ‘high/low’ blood glucose notification warning pop-ups for the bolus wizard software are not timing out which may lead to confusion. there are no reported harms due to the combination of potential user error and pop up screens not timing out.
Action
Medtronic has updated the user guide to rectify this issue. For more details, please see https://www.tga.gov.au/alert/minimed-640g-insulin-pump. This action has been closed-out on 15/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Baxter has determined that the product pouches for the affected lot numbers may have tears potentially causing a breach in the sterile barrier.
Action
Baxter is requesting their customers to return all affected products.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Extra notes in the data
Reason
Through customer complaints, hospira has become aware of customers using the incorrect size receptal liners with their receptal canisters, e.G., 2l liner or 3l liner with a 1.5l canister, which has resulted in a report of one death to date. there have been no reports of death or serious injury in australia. it is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent. hospira advises users to not use incorrectly sized receptal liners with receptal canisters. all receptal liner and canister list numbers are affected by this action.
Action
Hospira is advising hospitals to only use the correct size liners are used with the corresponding canister and to ensure that the liner is fully extended in the liner.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Bayer healthcare is recalling brackets used to mount the continuum pump on the iv pole distributed with non-wireless versions of medrad continuum mr infusion systems prior to march 2008. these brackets are being recalled because of a potential safety risk in the mri environment associated with locking pins which may become damaged and not restrain the pump from being attracted to the mri magnet.
Action
Imaxeon is requesting their customers to inspect their bracket immediately. If a bracket has a damaged pin end users are advised to cease use immediately and remove from the MR scan room. Undamaged brackets should be inspected every time a Continuum Pump is installed or removed until a replacemnt bracket is supplied.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The synchromed ii pump software update will automatically correct the following two issues:1) erroneous replace by date: the updated software corrects the issue previously communicated in medtronic’s march 2012 (tga ref: rc-2012-rn-00260-3) i.E., in some circumstances after a pump’s elective replacement indicator (eri) has occurred, the “schedule to replace the pump by” date may be incorrectly displayed as a series of question marks (??/??/????), or as a date greater than 90 days from the eri date, potentially leading to the pump reaching end of service (eos) prior to replacement.2) premature reservoir alarm: the updated software corrects the potential for premature low and empty reservoir alarms. these premature alarms are due to an incorrect calculation within the 8840 programmer software. the majority of these alarms occur within the clinic immediately following an interrogation.
Action
1) Medtronic does not recommend prophylactic explant of devices because these issues are addressed automatically and non-invasively with the software card update. Until the software application card is updated in the programmer:
- Clinicians may continue to use the present software card.
- Continue the normal follow up schedule, and monitor the estimated number of months until Elective Replacement Indicator (ERI).
- Follow labelled recommendations for pump replacement within 90 days of ERI declaration.
2) In the case of a low or empty reservoir alarm:
- Review the calculated residual volume displayed on the 8840 programmer to assess if the alarm is premature.
- After the software update, any previous version of the model 8870 software application card should no longer be used and can be returned to Medtronic.
For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-II-140204.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The issue relates to fasteners securing overhead lift rail systems to ceilings in chlorinated indoor pool applications. two complaints with no confirmed injuries have been reported to hill-rom that corrosion of the fasteners could lead to the rails becoming unattached and falling. hill-rom’s analysis has concluded that the root cause is stress corrosion cracking (scc) on the stainless steel hardware may occur in the presence of chlorinated environments such as swimming pool areas. there is a risk that continued use of the stationary lift in a chlorinated pool area could result in injuries to patients, caregivers or bystanders.
Action
Hill-Rom is advising users that an inspection will be carried out on all potentially affected systems located in a chlorinated environment and if systems are found to be of stainless steel hardware, it will be replaced with unaffected hardware. Hill-Rom is reminding users that periodic inspections are required for the rail systems in accordance with the Instructions for Use (IFU). For more details, please see http://www.tga.gov.au/safety/alerts-device-liko-overhead-lifts-140121.htm . This action has been closed-out on 11/02/2016.