Events

Recall of Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Distributed from 6 March 2012 to 31 December 2015

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-2016-RN-00460-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00460-1
  • 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
    Issues have been identified regarding the video display cables, video display assembly (internal pc board) and the pneumatic assembly for certain cardiosave hybrid and rescue iabps.1 - the cardiosave iabp may have intermittent connectivity issues with the video display cables causing display blanking followed by a “system failure” audible alarm and shut down.2 - the cardiosave iabp video display assembly may shutdown during operation due to a short on the video generator board.3 - intermittent connection with the cardiosave pneumatic module connector resulting in iabp startup failure and/or iabp shutdown.To date, there has been no reported patient harm or adverse events attributable to these issues.
  • Action
    Maquet is advising users to ensure an alternative device is available at all times as a backup, and that the affected units should not be used during ground or air transport. Maquet will be performing an on-site service to correct the reported issues. This action has been closed-out on 23/01/2017.

Device

Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Distributed from 6 Marc...
  • Model / Serial
    Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)Distributed from 6 March 2012 to 31 December 2015ARTG Number: 118266
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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