Events

Rappel de Heater Unit HU 35

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-00917-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-07-25
  • 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-00917-1
  • 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
    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
  • Modèle / numéro de série
    Heater Unit HU 35All Models and Serial NumbersARTG Number: 144010
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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