Events

Recall of CARDIOSAVE Hybrid IABP Intra-Aortic Balloon PumpCARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIOSAVE Hospital Cart RoHS

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getinge 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-2018-RN-00603-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-06-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00603-1
  • 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
    Getinge has received complaints involving the cardiosave iabps regarding ingress of fluids into the iabp affecting various electronic circuit boards. this situation would prevent initiation or continuation of therapy. to date, getinge has received one report of an adverse event in which one death was associated with a saline spill / liquid ingress.
  • Action
    Getinge are advising that affected sites will be contacted to schedule an on-site service of the Cardiosave IABP to install a protective top cover and perform a System Functional Test. Until Getinge have implemented the corrective actions above, users should adhere to the instructions outlined on the Customer Letter when using the Cardiosave IABP

Device

CARDIOSAVE Hybrid IABP Intra-Aortic Balloon PumpCARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIO...
  • Model / Serial
    CARDIOSAVE Hybrid IABP Intra-Aortic Balloon PumpCARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIOSAVE Hospital Cart RoHS Part Numbers: 0997-00-0562 and 0997-001-1179ARTG Number: 118266(Getinge Australia Pty Ltd - Circulatory assist unit, pump, balloon)
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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