Events

Recall of PCA LifeCare Infusion System

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-2013-RN-00292-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00292-1
  • 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
    Hospira has received reports of pca pumps not detecting distal occlusions, one of which resulted in serious injury. this issue is caused by wear and tear on the half nut which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
  • Action
    Hospira is recalling the affected pumps. The pumps have not been supplied since 2006.

Device

PCA LifeCare Infusion System
  • Model / Serial
    PCA LifeCare Infusion System Catalogue number: 0F7822703Number on pump: 0F782ARTG number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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