Events

Rappel de HICO - Variotherm 550 Hypothermia/Hyperthermia Unit

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01600-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01600-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    HICO - Variotherm 550 Hypothermia/Hyperthermia UnitPrevious ARTG number: 265557
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA