Events

Recall of Maquet/Datascope 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-2017-RN-00834-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00834-1
  • 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 identified a potential issue with the solenoid driver board within the unit of the cs100i, cs100 or cs300 iabp. a complaint was received involving a cs300 iabp that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure, which has been associated to a patient death due to the failure of the device to initiate therapy.An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. the lack of power prevents the coil from moving the plunger causing the valve not to open.These issues could result in an interruption and/or delay in therapy to the patient during use and/or prior to using their cs100i, cs100 or cs300 iabp. a sudden interruption of therapy could result in unsafe, haemodynamic instability. this issue also applies to any system 98 or system 98xt iabp which was converted to a cs100i or cs300 iabp.
  • Action
    Getinge advises: 1. Pursuant to the WARNINGS section of the Operating/User Instructions, clinicians are instructed not to leave the patient unattended during IABP therapy; 2. Until the service is performed, Getinge recommends powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform; 3. In the event the IABP fails to complete the self-test and exhibits electrical test failure code 58, remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office; 4. In the unlikely event that a sudden interruption of therapy occurs, transfer the patient to an alternative IABP. If an alternative IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate. Please refer to the intra-aortic balloon catheter instructions for use; and 5. Each affected facility will be contacted by Maquet/Getinge Service Team to schedule on-site service.

Device

Maquet/Datascope Intra-Aortic Balloon Pump (IABP)
  • Model / Serial
    Maquet/Datascope Intra-Aortic Balloon Pump (IABP)CS100i IABPPart Numbers: 0998-UC-0446HXX, 0998-UC-0479HXXCS100 IABPPart Numbers: 0998-00-3013-XX, 0998-UC-3013-XXCS300 IABPPart Numbers: 0998-00-3023-XX, 0998-UC-3023-XXDistributed between 24 March 2003 through to 11 December 2013ARTG Number: 118266
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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