Events

Recall of Alaris GP Large Volumetric Pump (general purpose infusion pump)

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-2012-RN-01162-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01162-1
  • 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
    Carefusion, through its post market surveillance system, learned that the alaris gp infusion system produces very small air bubbles (less than 50ul) which are too small to trigger the lower configurable air-in-line detection thresholds (alarm) of the alaris gp infusion system - being 50-500ul, as configured by the user or 1ml over a rolling 15 min. window, which is considered state of the art and in compliance with en60601-2-24: particular requirements for the safety of infusion pumps and controllers (according to swissmedic).
  • Action
    CareFusion is providing additional information and warnings in relation to at-risk groups of patients such as those with artial septal defect, neonates and those using multiple lines.

Device

Alaris GP Large Volumetric Pump (general purpose infusion pump)
  • Model / Serial
    Alaris GP Large Volumetric Pump (general purpose infusion pump)Product Ref: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-GAll serial numbersARTG number: 130389
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd