Events

Rappel de Spectra Optia Apheresis machine

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-2014-RN-00124-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-05
  • 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-00124-1
  • 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
    Terumo bcthas identified that pinhole leaks may occur due to stresses on the channel weld, particularly during long procedures on spectra optia. if leaks occur during use the procedure must be discontinued.Terumo bct has received reports relating to leaks in the channel of the tubing set of the spectra optia. these leaks have many different causes, including operator misloading. a very specific type of channel leak, a 'pinhole' leak at a specific location reported by customers primarily during long mnc procedures have been identified.
  • Action
    Terumo BCT is installing a modified filler at the next scheduled preventative maintenance to mitigate the risk of leakage. The device can continue to be used while awaiting the replacement filler. Users should be aware of the potential for leakage and cease any procedure if leakage is observed.

Device

Spectra Optia Apheresis machine

Manufacturer

Terumo BCT Australia Pty Ltd