Events

Rappel de Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP)

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-2014-RN-00365-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-27
  • 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-2014-RN-00365-1
  • 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
    The fan assembly for specific system 98/98xt, cs100/cs100i and cs300 iabps could potentially contain a misshapen retaining ring. this retaining ring could disengage within the fan assembly, causing the fan to stop rotating, which causes the power supply to overheat and the iabp to shut down without any visual or audible warning. patients receiving iabp therapy are in critical condition and a sudden interruption of therapy could result in unsafe haemodynamic instability.
  • Action
    Clinicians are instructed to not leave the patient unattended during IABP therapy. Maquet is reminding users of the current warning in the IABP operating instructions ie, the patient balloon should not remain inactive in the patient (i.e., no inflating or deflating) for more than 30 minutes, due to the potential for thrombus formation. In the unlikely event that this situation was to occur, transfer the patient to an alternative Datascope IABP. If an alternative Datascope IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate. A Maquet Service Representative will contact hospitals to schedule the replacement of the fan assembly.

Device

Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP)

Manufacturer

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