Events

Recall of CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia 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-00281-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00281-1
  • 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
    1 - there have been reported cases of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touchscreen) of the cardiohelp device. all manual settings are lost and the system will revert back to the original clinical settings.2 - through internal testing, it has been determined that there is a possibility that electromagnetic interference due to electric current fluctuations may cause pressure valves on the display to "freeze".
  • Action
    Maquet is providing work around instructions to prevent risk of injury to the patient in the unlikely event of the failure mode occurring during use. Maquet has updated its current CARDIOHELP-i software to version 3.3.2.0 and this will be installed by an authorised Maquet service technician.

Device

CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)
  • Model / Serial
    CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)Serial Number: All devices up to 90410628 excluding S/N 90410622 and 90410626ARTG Number: 179014
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA