Events

Recall of MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)

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-2013-RN-00104-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00104-1
  • 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 identified two potential issues with the hl30 device which will be addressed in a software upgrade. first, in rare instances, as a result of an accidental impact or bump to the pump head cover, the unit may stop. this stoppage is intended to occur by design whenever the pump head cover is opened during operation. however if it occurs due to a rapid impact, the unit may stop without an informational message explaining the reason for the stoppage. secondly, in a limited number of cases, the unit slave pump did not engage after cardioplegia pause.
  • Action
    Maquet is advising that if the unit stops, it can be reset by turning the potentiometer to zero. If the software anomaly with the cardioplegia module was to occur, the patient can be cross-clamped until the unit restarts, or transferred to another device. A Maquet Australia representative will be in contact with relevant staff at affected facilities to schedule the implementation of the corrective action.

Device

MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)
  • Model / Serial
    MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)All devices affectedARTG Number: 179104
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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