Events

Rappel de Maquet Heater-Cooler Unit HCU 40

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-2017-RN-00904-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-07-24
  • 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-2017-RN-00904-1
  • 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
    Maquet cardiopulmonary has developed and validated new and revised cleaning and disinfection procedure for hcu 40 including a routine disinfection protocol and a protocol for highly effective disinfection also effective against atypical mycobacteria in the water system to be implemented on all hcu 40 systems in the field.This update also includes the following actions:1. replacement of valves:existing valves will be replaced by successors with proven material compatibility with the new cleaning and disinfection procedure;2. replacement of flow sensors:in hcu 40 devices with serial number below 90440266 the mechanical flow sensor will also be replaced by its successor to ensure material compatibility with the new cleaning and disinfection procedure; and3. software update release 1.2.3.0:hcu 40 devices will be updated with the new software (release 1.2.3.0) including a new cleaning wizard guiding the user through the new cleaning and disinfection process step by step.
  • Action
    Actions to be taken by users: 1. The update on HCU 40 systems has to be performed by authorised Maquet service personnel according to the Update Instruction as soon as possible; 2. Fill out the supplied Acknowledgement Form and return it as soon as possible to your local Maquet representative; 3. Incorporate the new cleaning and disinfection procedures into operating processes, and conduct any necessary training; 4. Continue to monitor the hygiene (contamination levels) in accordance with internal practices; and 5. Immediately report any contamination findings to the local Maquet representative by filing a complaint.

Device

Maquet Heater-Cooler Unit HCU 40
  • Modèle / numéro de série
    Maquet Heater-Cooler Unit HCU 40All Serial Numbers below 90441000ARTG Number 144010
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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