Events

Rappel de Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter

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-2015-RN-00012-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-09
  • 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-2015-RN-00012-1
  • 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
    During manufacturing of the sterile, for patient-use, sensation and sensation plus iabc products, the ferrule cap is intended to be removed from the fiber-optic connection at the time of final packaging.Maquet have identified that during the packaging of some demonstration, fiber-optic sensation and sensation plus iabc units, the ferrule cap was not removed. if the fiber-optic connector on an affected non-sterile, non-patient use, demonstration unit is inserted into patient-use maquet cs300, cardiosave intra-aortic balloon pump (iabp) or iabps upgraded with a fiber-optic module, the cap may become dislodged and remain in the fiber-optic receptacle of the pump.If a pump unit is subsequently used with a clincal use fiber optic balloon catheter inserted into the mating connector, the catheter will notmake an electrical connection with the iabp. the catheter will not be recognised as a fiber optic catheter. the system will still be able to pump as a non fiber optic balloon.
  • Action
    Maquet is providing instructions for the inspection of the demonstration units and the Intra-Aortic Balloon Pumps. End users are requested to inspect and remove the Ferrule caps if present on the pump of demonstration catheter. A Maquet technician will inspect potentially affected devices if required. This action has been closed-out on 11/08/2016.

Device

Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter
  • Modèle / numéro de série
    Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter ARTG Number: N/A Demonstration model only
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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