Events

Rappel de Spectra Optia Apheresis Systems

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-2017-RN-00626-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-16
  • 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-2017-RN-00626-1
  • 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 routine testing by the manufacturer, a device that is similar to the spectra optia system demonstrated a non-recoverable power failure. a subsequent investigation determined that a power filter cable, a component used in the internal electrical system, had a visible defect that caused the unit to lose power. specific serial numbers of the spectra optia systems contain these cables and therefore there is a possibility these systems could encounter a non-recoverable power failure. if a power failure occurs prior to starting the procedure, the failure could result in the delay of the procedure until the device is repaired or another device is available. if a power failure occurs after the procedure has begun, the procedure cannot be completed, and automated rinseback cannot be performed.To date, the manufacturer has not received any customer reports of a non-recoverable power failure experienced in any spectra optia system with the possibly affected cables.
  • Action
    Terumo is advising users that they will be replacing the affected cables. A Terumo sales representative will contact users to schedule a visit for the cable replacement. In the interim, the Spectra Optia system can continue to be used in accordance with the operator’s manual and the operator training materials, which include instructions for manual rinseback.

Device

Spectra Optia Apheresis Systems
  • Modèle / numéro de série
    Spectra Optia Apheresis SystemsSerial Number Range: 1P04028 to 1P04392ARTG Number: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd