Events

Rappel de Terumo Advanced Perfusion System 1

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Terumo Cardiovascular Systems Inc.

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
    13952
  • Date de mise en oeuvre de l'événement
    2012-12-18
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Cause
    Manufacturer has recveived 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-boted 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
    Instructions for use to be updated

Device

Terumo Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Inc