Events

Rappel de Advanced Perfusion System 1 (heart-lung bypass 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 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-01216-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-11-29
  • 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-01216-1
  • 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 received five reports between 2003 and 2012 of spontaneous power loss to the terumo system 1. in all reports the systems lost full power and did not switch to battery backup without warning. in one report the system re-booted automatically after about 30 seconds and in the remaining reports the system regained power after toggling the main power switch. in all of the reports the user was able to establish full function for the remainder of the case and the system did not exhibit the malfunction again.
  • Action
    An update to the instructions for use (IFU) is being issued to customers as an interim measure and the manufacturer's investigation into the root cause investigation is ongoing. Terumo is advising that should the investigation conclude that a corrective action is necessary, users will be notified.

Device

Advanced Perfusion System 1 (heart-lung bypass machine)
  • Modèle / numéro de série
    Advanced Perfusion System 1 (heart-lung bypass machine)Product Code: 801764Batch Numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027 & 1100-1429ARTG Number: 93976
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd