Events

Safety Alert Or Field Safety Notices for Plum A+ infusion pumps

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 Inc.

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/2011/066
  • Date
    2011-06-08
  • 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-infusion-pumps-potential-failure
  • 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
    Risk of delay or interruption to treatment.The audible alarm on all listed Plum A+ infusion pumps may fail.The visual alarm is not affected. However, if the user does not notice the visual alarm they may be unaware of an interruption to the infusion eg air-in-line or occlusion.Improper mounting of components, poor soldering, and breakage of internal wiring connections may lead to failure of the audible alarm.The manufacturer’s FSN (905Kb) advises users to test the audible alarm before each use of the pump as an interim measure. However, these tests will not predict if the audible alarm will fail and will only indicate if it has already failed. It is possible for the audible alarm to fail in use, even after the test has been performed.Hospira is modifying the design of the audible alarm to resolve this problem. Once this has been completed, Hospira will contact users to arrange for replacement.
  • Reason
    (hospira inc) audible alarm on listed plum a+ infusion pumps may fail, which could cause a delay or interruption to treatment. (mda/2011/066).
  • Action
    Identify affected pumps. Consider using an alternative device if an undetected interruption to an infusion could compromise patient safety. If an alternative is not available, perform the pre-use checks detailed in the manufacturer’s manufacturer’s FSN (905Kb) (dated 2 March 2011). Be aware that the audible alarm may still fail in some pumps even after the checks have been completed.

Device

Plum A+ infusion pumps
  • Model / Serial
  • Product Description
    All Plum A+ infusion pumps:Pump    List number  Plum A+ Infusion Pump    11971  Plum A+ 3 Infusion Pump System v 10.3    12348  Plum A+ Infusion Pump v 11.3    12391  Plum A+ 3 Infusion Pump v 11.3    12618  Plum A+ 3 with Hospira MedNet Software    20678  Plum A+ Driver    20792Manufactured by Hospira Inc.
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Manufacturer Address
    Robert Cookes Customer Services Manager Hospira UK Queensway Royal Leamington Spa CV31 3RW Tel: 0800 028 7304 Fax: 0800 028 7305Email: custserv@hospira.com
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    MHRA