Events

Rappel de CARDIOSAVE Hybrid IABP Intra-Aortic Balloon PumpCARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIOSAVE Hospital Cart RoHS

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getinge 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-2018-RN-00603-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-06-29
  • 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-2018-RN-00603-1
  • 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 received complaints involving the cardiosave iabps regarding ingress of fluids into the iabp affecting various electronic circuit boards. this situation would prevent initiation or continuation of therapy. to date, getinge has received one report of an adverse event in which one death was associated with a saline spill / liquid ingress.
  • Action
    Getinge are advising that affected sites will be contacted to schedule an on-site service of the Cardiosave IABP to install a protective top cover and perform a System Functional Test. Until Getinge have implemented the corrective actions above, users should adhere to the instructions outlined on the Customer Letter when using the Cardiosave IABP

Device

CARDIOSAVE Hybrid IABP Intra-Aortic Balloon PumpCARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIO...
  • Modèle / numéro de série
    CARDIOSAVE Hybrid IABP Intra-Aortic Balloon PumpCARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIOSAVE Hospital Cart RoHS Part Numbers: 0997-00-0562 and 0997-001-1179ARTG Number: 118266(Getinge Australia Pty Ltd - Circulatory assist unit, pump, balloon)
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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