Events

Rappel de Spectra Optia Apheresis System with Software Version 11

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-00963-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-09-05
  • 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-00963-1
  • 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
    A defect in optia version 11 sw can cause an unexpected behaviour to the rinseback option when the wbc or platelet counts are updated during the run and they are sufficiently different from the previous counts. the absence of rinseback could result in loss of rbc potentially resulting in limited illness or injury. unintended rinseback carried out on a very small patient could result in symptomatic hypervolemia. no serious injury or deaths have been associated with this behaviour.
  • Action
    Terumo BCT is actively working on a software update to correct this behaviour. Once this software is available affected devices will be updated. End users are being provided work around instructions to ensure the continued safe use of the device. This action has been closed-out on 14/07/2016.

Device

Spectra Optia Apheresis System with Software Version 11
  • Modèle / numéro de série
    Spectra Optia Apheresis System with Software Version 11 Catalogue Number: 61000ARTG Numbers: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd