Events

Recall of Heater Unit HU 35

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-00917-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00917-1
  • 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 released revised disinfection procedure for heater unit hu 35. heater unit hu 35 is used during extracorporeal life support (ecls) in intensive care units to maintain the patient’s blood temperature via an oxygenator heat exchanger. there is no contact between the blood stream of the patient and the system water circulating through the heat exchanger. maquet cardiopulmonary as well as different national competent authorities have received isolated reports confirming the presence of bacterial contamination in the system water of hu 35 including mycobacterial counts. however, maquet cardiopulmonary has not received any reports that a mycobacterial infection or any other bacterial infection would have been caused by a heater unit hu 35.
  • Action
    The current published Instructions for Use chapter 6 “Cleaning and Disinfection” for HU 35 Heater Units will be replaced by a new Instructions for Use (IFU). Action to be taken by the user: 1. Complete and return the enclosed Acknowledgement Form as soon as possible to your local Maquet representative; 2. Incorporate this revised procedure into your operating processes; 3. Conduct any training necessary for the revisions; 4. Continue to monitor the hygiene (contamination levels) in accordance with your internal practices; 5. Immediately report any contamination findings to your local Maquet representative by a complaint; and 6. Remind all users that the HU35 is not to be opened or filled in the operating room.

Device

Heater Unit HU 35
  • Model / Serial
    Heater Unit HU 35All Models and Serial NumbersARTG Number: 144010
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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