Events

Recall of Communication Engine in Plum A+ and A+3 Infusion Pump

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

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-2014-RN-00140-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-02-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00140-1
  • 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.
    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
    Some plum a+/a+3 devices contain a communication engine which communicates wirelessly with hospira mednet over a facility's local area network (lan). hospira has received several reports indicating that the communication engine in some plum a+/a+3 devices experiences difficulty downloading a custom drug library as indicated by an appropriate error message.
  • Action
    Hospira are advising users that if a custom drug library fails to download and experiences an error message, please report the issue to Hospira. Hospira will make arrangements to identify and correct the Communication Engine.

Device

Communication Engine in Plum A+ and A+3 Infusion Pump
  • Model / Serial
    Communication Engine in Plum A+ and A+3 Infusion Pump Plum A+Pump: 12391 & 20792Communication Engine Modules:20677 & 20791 (respectively)Plum A+3Pump: 20678Communication Engine Modules: 20678ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DHTGA