Events

Recall of Curlin 6000 and Painsmart IOD Ambulatory Infusion Pumps

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fresenius Kabi Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00053-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00053-1
  • Notes / Alerts
    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 master pumps used to calibrate the pumps that were manufactured or serviced from the 18th of march 2015 to the 6th of november 2015 were out of tolerance. use of affected pumps may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed. likewise the volume to be infused (vtbi) may be depleted earlier than expected resulting in delivery of overfill contained in the iv bag, if overfill is present. if overfill is not present, the pump may present an air in line or upstream occlusion alarm once the iv bag has emptied. as expected, the pump will stop infusing when either of these alarms occurs.While the potential inaccuracy of the affected pumps may be only a small fraction over the stated accuracy of the system, certain populations of patients may be affected more than others. over delivery, or delivering at a rate of 1.2 - 6.8% faster than intended, may cause adverse serious injuries in certain patient populations.
  • Action
    Users are advised that Fresenius Kabi Australia have undertaken a “Pre-Delivery Inspection” which included volumetric accuracy test and all the pumps in affected facilities have passed the accuracy test at the time of delivery. Fresenius Kabi representative will contact customers to arrange a time to re-calibrate the affected pumps. In the interim, users are advised to quarantine the affected pumps provided they have access to enough alternative pumps. If this is not the case, users may continue to use the affected infusion pump if a patient is deemed not to be at risk from faster than intended delivery of a medication/fluid (up to 6.8% faster). However for high-risk patients, such as those receiving inotropes or opioids and patients with renal failure, congestive heart failure or paediatric patients, an alternative pump should be sourced. This action has been closed-out on 03/03/2017.

Device

Curlin 6000 and Painsmart IOD Ambulatory Infusion Pumps
  • Model / Serial
    Curlin 6000 and Painsmart IOD Ambulatory Infusion PumpsCurlin 6000 Ambulatory Infusion PumpProduct Code: 360-1400-PMultiple Serial Numbers affectedPainsmart IOD Infusion PumpProduct Code: 360-1300-PE5Multiple Serial Numbers affectedARTG Number: 225964
  • Manufacturer
    Fresenius Kabi Australia Pty Ltd

Manufacturer

Fresenius Kabi Australia Pty Ltd