Events

Rappel de Spectra Optia Apheresis SystemAll Serial Numbers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Terumo BCT 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-00924-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-09-26
  • 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-00924-1
  • 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 manufacturer has become aware that the spectra optia system's return line air detector (rlad) can potentially fail as a result in a non-continuable alarm condition. if air has been falsely detected due to a defective rlad during a procedure, a continuous "air detected in return line" alarm will occur and will not allow the procedure to continue. if the rlad experiences a defect during prime, the system will generate a "return line air detector failed fluid check" alarm and will not allow the procedure to be performed until serviced.
  • Action
    Terumo BCT is providing work around instructions for users to follow.

Device

Spectra Optia Apheresis SystemAll Serial Numbers

Manufacturer

Terumo BCT Australia Pty Ltd