Events

Recall of Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (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-2014-RN-00365-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00365-1
  • 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
    The fan assembly for specific system 98/98xt, cs100/cs100i and cs300 iabps could potentially contain a misshapen retaining ring. this retaining ring could disengage within the fan assembly, causing the fan to stop rotating, which causes the power supply to overheat and the iabp to shut down without any visual or audible warning. patients receiving iabp therapy are in critical condition and a sudden interruption of therapy could result in unsafe haemodynamic instability.
  • Action
    Clinicians are instructed to not leave the patient unattended during IABP therapy. Maquet is reminding users of the current warning in the IABP operating instructions ie, the patient balloon should not remain inactive in the patient (i.e., no inflating or deflating) for more than 30 minutes, due to the potential for thrombus formation. In the unlikely event that this situation was to occur, transfer the patient to an alternative Datascope IABP. If an alternative Datascope IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate. A Maquet Service Representative will contact hospitals to schedule the replacement of the fan assembly.

Device

Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP)

Manufacturer

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