Events

Recall of Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion Pumps

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 Pty Ltd.

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-00584-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00584-1
  • 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.
  • Extra notes in the data
  • Reason
    Post market surveillance has identified an increased occurrence of stepper motor stalls due to the rear bearings not performing as designed.A motor stall condition may occur during:- start up (immediately after the start key is pressed) or;- during an infusion which may result in the early termination of an infusion. early termination of an infusion could require intervention especially if critical drugs are being administered.In either case the pump is designed to fail safe giving an audible alarm, a visual alarm displayed on the infusion pump display - "drv1" or "drv2" and the red beacon light on the infusion pump will flash, prompting the infusion pump user to intervene.
  • Action
    End users are requested to identify all affected infusion pumps and report back to their Carefusion representative. On receipt of this information Carefusion will organise for the replacement of the motor. The infusion pumps can be continued to be used in accordance with the instructions for use. In the unlikely event that end users experience a 'DRV1' or 'DRV2' error quarantine the pump and contact your Carefusion representative immediately.

Device

Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion Pumps
  • Model / Serial
    Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion PumpsProduct reference numbers: 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-GPumps manufactured between Dec 2009 and Jan 2012ARTG number: 130389
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd