Events

Rappel de ADVANCED PERFUSION SYSTEM 1 - MODULES

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TERUMO CARDIOVASCULAR SYSTEMS CORP..

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
    153878
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-08-10
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Terumo cardiovascular systems (terumo cvs) has received ten reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities using the following modules for the terumo advanced perfusion system 1: serial interface module rs-232 serial interface module rs-485 interface module for cdi system 100/101 interface module for cdi system 500. 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.

Device

ADVANCED PERFUSION SYSTEM 1 - MODULES
  • Modèle / numéro de série
    Model Catalog: 803479 (Lot serial: 00366-00498 (802113)); Model Catalog: 802113 (Lot serial: 00366-00498 (802113)); Model Catalog: 803518 (Lot serial: 00216-00283 (802113)); Model Catalog: 803479 (Lot serial: 00216-00283 (802113)); Model Catalog: 802113 (Lot serial: 00216-00283 (802113)); Model Catalog: 803518 (Lot serial: 00123-00214 (802113)); Model Catalog: 803479 (Lot serial: 00123-00214 (802113)); Model Catalog: 802113 (Lot serial: 00123-00214 (802113)); Model Catalog: 803518 (Lot serial: 00080-00121 (802113)); Model Catalog: 803479 (Lot serial: 00080-00121 (802113)); Model Catalog: 802113 (Lot serial: 00080-00121 (802113)); Model Catalog: 803518 (Lot serial: 00066-00077 (802113)); Model Catalog: 803479 (Lot serial: 00066-00077 (802113)); Model Catalog: 802113 (Lot serial: 00066-00077 (802113)); Model Catalog: 803518 (Lot serial: 00047-00064 (802113)); Model Catalog: 803479 (Lot serial: 00047-00064 (802113)); Model Catalog: 802113 (Lot serial: 00047-00064 (802113)); Model Catalog: 803518 (Lot serial: 00
  • Description du dispositif
    SERIAL INTERFACE MODULE RS-232 INTERFACE MODULE FOR CDI SYSTEM 500 SERIAL INTERFACE MODULE RS-485
  • Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS CORP.
  • Adresse du fabricant
    ANN ARBOR
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    HC