Events

Rappel de TCVS Heart lung machine

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
    20239
  • Date de mise en oeuvre de l'événement
    2016-06-02
  • 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
    Terumo cardiovascular systems (terumo cvs) has received reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities. some reports stated that the odor of smoke was associated with the failures. the malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. terumo cvs' investigation has determined that the malfunctions are caused by a circuit board that failed.
  • Action
    Product to be exchanged

Device

TCVS Heart lung machine
  • Modèle / numéro de série
    Model: Serial interface module RS-232, Serial interface module RS-485, Interface module for CDI System 100/101, Interface module for CDI System 500, Affected: Interface Module
  • Manufacturer
    Terumo Cardiovascular Systems Inc

Manufacturer

Terumo Cardiovascular Systems Inc