Events

Recall of HICO - Variotherm 550 Hypothermia/Hyperthermia Unit

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-2016-RN-01600-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01600-1
  • 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
    It has come to the attention of maquet australia that the hico-variotherm 550 hypothermia/hyperthermia unit has been supplied under the incorrect intended purpose of heat exchange control unit for extra corporeal membrane oxygenation. as described in the operating instructions document supplied with the device, the variotherm is solely intended for the cooling or heating of water mats used to cool or warm a patient. utilising the variotherm for heat exchange control across a gas exchange membrane in extra corporeal membrane oxygenation (ecmo) is against the intended use of the device and is incompatible with maquet oxygenators due to the associated cleaning procedures outlined in the user manual of the variotherm unit. in particular the germicidal agent (sanosil, hydrogen peroxide) that is recommended to be added to the tank water after the final flush (prior to use) is not suitable for use with maquet oxygenators.
  • Action
    Customers are advised to ensure that the intended purpose as indicated in the user manual is being complied with at their facilities. Maquet is offering to replace the Variotherm with units with an ECMO indication and customers are advised to contact their Maquet representative to arrange the replacement, if needed.

Device

HICO - Variotherm 550 Hypothermia/Hyperthermia Unit
  • Model / Serial
    HICO - Variotherm 550 Hypothermia/Hyperthermia UnitPrevious ARTG number: 265557
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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