Events

Recall of CARDIOSAVE Hybrid and Rescue Intra-aortic Balloon Pumps (IABP) (Used to inflate and deflate intra-aortic balloons for temporary support of the left ventricle via the principle of counter-pulsation)

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-00265-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-03-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00265-1
  • 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 has received reports that, in some cardiosave iabps, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates. when the scroll compressor fails, one of two high priority alarms will appear on the iabp display and patient therapy could be interrupted. the high priority alarms are “autofill failure” and “iab catheter restriction”. if either of the high priority alarms cannot be resolved, the event may be attributable to the scroll compressor failure and therapy to the patient cannot be manually restarted.In this situation and where supported by the iabp to stabilise their haemodynamic status, patients present with critical conditions (particularly those in transit), there is a risk for severe and possible irreversible injury.There are no complaints reported associated with a patient injury or death.
  • Action
    Maquet is providing work around instructions for users to follow as an interim measure. A software upgrade will be installed as a permanent correction. An updated operator’s manual is being provided which includes additional important information regarding the configuration, alarms in the presence of ESI and self-checks for the compressor. Users are advised the units can continue to be used while the software is being implemented, however it is recommended that if available, they use an alternative unaffected device based on the individual benefit-risk assessment and particularly for patients in transit. If users choose to use an affected CARDIOSAVE IABP it is recommended that an alternative device is available for back-up.

Device

CARDIOSAVE Hybrid and Rescue Intra-aortic Balloon Pumps (IABP) (Used to inflate and deflate intra...
  • Model / Serial
    CARDIOSAVE Hybrid and Rescue Intra-aortic Balloon Pumps (IABP) (Used to inflate and deflate intra-aortic balloons for temporary support of the left ventricle via the principle of counter-pulsation)Part Numbers: 0998-00-0800-XX and 0998-UC-0800-XXDistributed between 6 March 2012 to 20 October 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