Events

Rappel de TCVS Terumo/Sarns Disposable Centrifugal Pump

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
    16613
  • Date de mise en oeuvre de l'événement
    2014-05-01
  • 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 received complaints of the sarns disposable centrifugal punps leaking due to a crack in the molded separator. in all but one report, the leaks were discovered during priming of the cardiopulmonary (cpb) circuit and prior to initiating cpb. in these instances the centrifugal pump was successfully changed out with no delays in the surgical procedures., in one report the failure occurred during cpb and the pump was not replaced.
  • Action
    Product to be returned to supplier

Device

TCVS Terumo/Sarns Disposable Centrifugal Pump

Manufacturer

Terumo Cardiovascular Systems Inc