Events

Recall of Alaris System PC Unit model 8015

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-2015-RN-00289-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00289-1
  • 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 usa (the manufacturer) has identified an issue with the pc unit model 8015 following receipt of reports from customers experiencing a system error. a system error (code 110.6021) is displayed with concurrent audio and visual alarm, however it cannot be cleared by restarting or rebooting the pc unit. the error code may occur upon power on during the “power-on self test” due to a keypad issue. the power-on self test is designed to occur during power on, in order to detect issues prior to initiation of an infusion. the system cannot be cleared by restarting or rebooting the pc unit.
  • Action
    CareFusion will replace the affected front keypad assembly on the Alaris PC unit. In the interim end users have been provided with work around instructions to minimise risk to patients. This action has been closed-out on 12/08/2016.

Device

Alaris System PC Unit model 8015
  • Model / Serial
    Alaris System PC Unit model 8015Material Codes: 8015LSBIXEN9121; 8015LSAIXE9121; 8015LSCIXE91240; 12279909Manufactured between September 1, 2012 and October 22, 2013 having a 5.7” screenARTG Number: 146666
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd