Events

Recall of CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

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-00099-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00099-1
  • 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
    Suboptimal thermal management of the power supply may result in the power supply not providing the correct output voltage to the cardiosave hybrid iabp console, and the inability to charge the batteries. failure to provide the correct output voltage to the console will result in the unit not functioning from ac power, even when plugged into an active electrical outlet. should a power supply malfunction occur, an on screen message will alert the healthcare provider that the cardiosave hybrid iabp unit is operating on battery power. the hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy.
  • Action
    Users are advised that in the unlikely event that the failure mode was to occur, transfer the patient to an alternative Maquet IABP. If an alternative Maquet IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate. Users are advised to refer to the IAB Instructions for Use, Manually Inflating and Deflating a Catheter. The IAB Instructions for Use reiterates that a catheter should not remain inactive for more than 30 minutes, due to the potential for thrombus formation. Alternatively, the IAB could be removed. Maquet anticipates having a replacement power supply available by June 2015. A service representative will contact affected customers to schedule the replacement of the cart power supply. This action has been closed-out on 11/08/2016.

Device

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
  • Model / Serial
    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)Model Numbers: 0998-00-0800-XX and 0998-UC-0800-XX (excluding 0998-00-0800-83)ARTG Number: 118266
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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