Events

Recall of Alaris System Infusion PC Unit

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-2016-RN-00793-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00793-1
  • 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
    Alaris pc units model 8015 manufactured between september 11, 2012 and march 29, 2013 may display a system error code 133.6080 due to a failure with the super capacitor (c245) at power up on the alaris pc unit logic boards. the error code will cause an audible and visual alarm to sound and could cause a delay of therapy at power up only. the error code will not occur during infusion.
  • Action
    Carefusion is advising users that if the error code is observed, to remove the unit from use and use a different unit where available. Carefusion will be correcting all affected units.

Device

Alaris System Infusion PC Unit
  • Model / Serial
    Alaris System Infusion PC UnitModel Number: 8015Manufactured between 11 September 2012 and 29 March 2013ARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd