Events

Safety Alert Or Field Safety Notices for Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Hospira.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2013/078
  • Date
    2013-11-04
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-plum-a-and-a-3-family-of-infusers-gemstar-infuser-and-lifecare-pca-infuser-ce-marking-withdrawn
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    The CE marking for these pumps has been withdrawn.Hospira will not be able to supply any new pumps. However, they can continue to supply consumables for pumps already in use.There are a number of current Field Safety Notices detailing faults that may lead to over-infusion, low infusion rates or an interruption to therapy. The manufacturer’s proposed corrective actions for the Plum pumps (which include design changes) will not be carried out in the UK at this time, as their safety and performance have not been subjected to independent assessment by a notified body.In March 2013 the MHRA issued Medical Device Alert MDA/2013/016 in relation to the Gemstar infusers. The relevant Field Safety Notices are:Pressure sensor calibration drift (920Kb) (dated 21 March 2013)
    Battery leakage may lead to shut down (528Kb) (dated 20 June 2013), an update to FSN 21 March (785Kb) 2013
    Lithium battery low voltage (752Kb)(dated 21 March 2013)
    Backward motor movement (522Kb)(dated 31 July 2013), an update to FSN 21 March (785Kb) 2013In February 2013 we issued MDA/2013/006 in relation to the Plum A+ and A+3 family of infusers. The relevant Field Safety Notices are:Battery not fully charging (845Kb)  (dated 19 February 2013)
    Volume control knob (457Kb)  (dated 29 October 2012)
    Door roller assembly (2746Kb)   (dated 12 December 2012)
    Distal pressure sensor calibration (61Kb)  (dated 14 February 2013)
    Fluid ingress (991Kb) (dated 25 January 2013)
    Fluid shield diaphragm (84Kb) (dated 24 January 2013)
    Distal pressure sensor pin fracture (92Kb) (dated 24 January 2013)
    Recycling / rebooting (3252Kb) (dated 21 September 2013).  
    Please note that although MDA/2011/110and the related Field Safety Notices indicated that a software update would be provided, Hospira have now stated that, on review, the UK market is not affected by this issue.
  • Reason
    (hospira) use an alternative pump, where available. (mda/2013/078).
  • Action
    Gemstar and Plum pumpsUse an alternative pump, where available. If an alternative is not available: assess the risks/benefits associated with the use of these pumps for each individual patient when administering therapies ensure that staff are aware of all the issues highlighted in the manufacturer’s Field Safety Notices, and MDA/2013/006 and MDA/2013/016 exercise caution in use report any adverse incidents involving these devices to the MHRA.Gemstar pump onlyHospira are offering the Sapphire pump, manufactured by Q Care, on a part exchange basis. Contact Hospira to discuss options for your hospital.

Device

Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser
  • Model / Serial
  • Product Description
    Infusion pumps.Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser.Manufactured by Hospira. All models and list numbers.
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Address
    Manufacturer’s authorised representativeJohn McIlvaney Customer Services Manager Hospira UK Queensway Royal Leamington Spa Tel: 0800 028 7304Email: custserv@hospira.com
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    MHRA