Events

Recall of CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0

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-2015-RN-00117-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00117-1
  • 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
    Maquet cardiopulmonary has received several complaints from the field reporting that after startup with either ac or dc power, the cardiohelp system generated the pop-up window "battery x needs service" or "both batteries need service" (x refers to the number of built-in battery, e.G.Battery 1). the alarm messages did not occur during device operation (including the switch from ac to dc power and vice versa) .Maquet cardiopulmonary's internal investigations have identified that there is a likely occurrence of the above mentioned error messages due to software bugs in the communication between the controller module and operating system . however, it is not possible for the user to distinguish the genuine alarm messages caused by batteries from the incorrect alarm messages caused by the software bugs. maquet cardiopulmonary received no reports of any adverse patient outcomes as a result of this error message.
  • Action
    The new software version (version 3.4.6.0) corrects software bugs that resulted in the generation of incorrect "Battery Needs Service" error messages. This software revision and the method for upgrading affected systems will be provided via the normal Service Letter process. This action has been closed-out on 11/08/2016.

Device

CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0
  • Model / Serial
    CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0 ARTG Number: 179104
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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