Events

Rappel de ADVANCED PERFUSION SYSTEM 1 - BASE UNIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par RYAN MEDICAL DISTRIBUTORS 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
    137887
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-09-14
  • 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 multiple reports of false alarms generated by the air bubble detection system used with the terumo advanced perfusion system 1 the sarns modular perfusion system 8000 and the sarns perfusion system 9000. terumo cvs' investigation determined that prior corrective actions on the sensor (in 2007 and 2010) did not fully eliminate the possibility for malfunction. therefore terumo cvs has concluded that it is necessary to amend the operator's manuals for its heart-lung machines to: - alert all users of the potential for a malfunction of the air bubble detection system - reinforce the mitigation procedures in the event of a malfunction.

Device

ADVANCED PERFUSION SYSTEM 1 - BASE UNIT
  • Modèle / numéro de série
    Model Catalog: 801763 (Lot serial: 1361); Model Catalog: 801763 (Lot serial: 0017); Model Catalog: 801763 (Lot serial: 0020); Model Catalog: 801763 (Lot serial: 0021); Model Catalog: 801763 (Lot serial: 1412); Model Catalog: 801763 (Lot serial: 1411); Model Catalog: 801763 (Lot serial: 1374); Model Catalog: 801763 (Lot serial: 1367); Model Catalog: 801763 (Lot serial: 0013); Model Catalog: 801763 (Lot serial: 1360); Model Catalog: 801763 (Lot serial: 1340); Model Catalog: 801763 (Lot serial: 1312); Model Catalog: 801763 (Lot serial: 1177); Model Catalog: 801763 (Lot serial: 0396); Model Catalog: 801763 (Lot serial: 0193); Model Catalog: 801763 (Lot serial: 0170); Model Catalog: 801763 (Lot serial: 0146); Model Catalog: 801763 (Lot serial: 0144); Model Catalog: 801763 (Lot serial: 0142)
  • Description du dispositif
    TERUMO ADVANCED PERFUSION SYSTEM 1: OPERATOR'S MANUAL ULTRASONIC AIR SENSOR
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.