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
    20973
  • Date de mise en oeuvre de l'événement
    2016-12-21
  • 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
    The manufacturer has received reports of instances in which the 6 roller pump for the terumo advanced perfusion system 1 displayed a pump jam message and stopped while in use. investigation concluded that, while there is no specific evidence that the 6 roller pumps were operating outside manufacturing specifications:, 1. pump jam is more likely to occur when using the 6 roller pump for low-rpm cardioplegia delivery than when using the 4 roller pump for dual-sized tube set cardioplegia delivery., 2. the occlusion settings suggested in the operator's manual for some dual-sized tubing sets may increase the likelihood of pump jam on the 6 roller pump.
  • Action
    Manufacturer to issue advice regarding use

Device

TCVS Heart lung machine

Manufacturer

Terumo Cardiovascular Systems Inc