Events

Rappel de HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)

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-2012-RN-01015-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-10-02
  • 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-2012-RN-01015-1
  • 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
    In some very rare cases, it was not possible to insert the guide wire through the introducer of the hls-cannulae. the investigation identified that the hole in the grip of the introducer was partly blocked and the guide wire could not be pushed through. the problem occurs prior to vascular access and the cannulae itself functions properly during perfusion.
  • Action
    Quarantine and return affected devices to MAQUET

Device

HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as ...
  • Modèle / numéro de série
    HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)Multiple catalogue and lot numbersARTG Numbers: 188929 and 189286
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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