Events

Field Safety Notices about ALL HOSPIRA PLUM A+/A+3 FAMILY OF INFUSERS

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland 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
    Field Safety Notice
  • Event Number
    SN2013(02)
  • Date
    2013-03-26
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/all-hospira-plum-a-a-3-family-of-infusers&id=377cf825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
    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
    Hospira has circulated ten field safety notices (fsns), since october 2011, advising of various issues relating to the plum a+/a+3 family of infusers which could result in overdose, under-dose or a delay/interruption in therapy.
  • Action
    1. Ensure that the appropriate personnel are made aware of this notice and the attached Caution in Use FSN.  2. Identify affected pumps.  3. The manufacturer and the IMB advise users to weigh the risk/benefit to patients associated with the use of these devices when administering critical therapies.  4. Customers should consider the use of an alternative pump, particularly in patients in which an overdose, under-dose or delay/interruption in therapy could compromise patient safety.  5. Follow the manufacturer’s recommendations in the attached Caution in Use FSN.

Device

ALL HOSPIRA PLUM A+/A+3 FAMILY OF INFUSERS
  • Model / Serial
  • Product Description
    ALL HOSPIRA PLUM A+/A+3 FAMILY OF INFUSERS
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    HPRA