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 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-2017-RN-00991-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00991-1
  • 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/getinge has received complaints involving the cs100/cs100i and cs300 iabps regarding the following issues:1. false blood detection alarm; and2. the ingress of fluids into the iabp affecting various electronic circuit boards.No serious injuries to patients have been reported as of august 2017.
  • Action
    Each affected facility will be contacted by a representative of the Getinge Service Team to schedule on-site service of the CS100/CS100i or CS300 IABP

Device

Maquet/Datascope Intra-Aortic Balloon Pump (IABP)
  • Model / Serial
    Maquet/Datascope Intra-Aortic Balloon Pump (IABP)Product Numbers: CS100i IABP, CS100 IABP, CS300 IABPPart Numbers: 0998-UC-0446HXX, 0998-UC-0479HXX, 0998-00-3013-XX, 0998-UC-3013-XX, 0998-00-3023-XX, 0998-UC-3023-XXARTG Number: 118266
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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