Events

Rappel de HEART LUNG PERFUSION PACK WITH SOFTLINE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MAQUET-DYNAMED 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
    15307
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-01-28
  • 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
    The desired cardioplegia temperature may not be obtained when the plegiox cardthe desired cardioplegia temperature may not be obtained when the plegiox cardioplegia heat exchanger (plegiox) is used in conjunction with a heater/cooler ioplegia heat exchanger (plegiox) is used in conjunction with a heater/cooler unit. isolated field reports have indicated that a user could not reach a desired low cooling temperature of cardloplegic solution as the measured value of the cardioplegia temperature by the probe on the plegiox did not match the set temperature on the heater/cooler unit. this variation has been attributed to the position of the temperature probe at the port on the plegiox which may lead to temperature readings differing to a varying degree from the real temperature of the cardioplegic solution. the discrepancy between cardioplegia temperature measured at the probe of the plegiox and set water temperature on the heater/cooler unit may appear greater than typical during clinical use of the heater/cooler system.

Device

HEART LUNG PERFUSION PACK WITH SOFTLINE
  • Modèle / numéro de série
    Model Catalog: BO-HQV 48707 (Lot serial: 92122544); Model Catalog: BO-HQV 48707 (Lot serial: 92120338); Model Catalog: H 55807 (Lot serial: 92119752); Model Catalog: H 55807 (Lot serial: 92121728); Model Catalog: H 55807 (Lot serial: 92120638); Model Catalog: H 55807 (Lot serial: 92112815); Model Catalog: H 55807 (Lot serial: 92118294); Model Catalog: H 55807 (Lot serial: 92115326); Model Catalog: H 55807 (Lot serial: 92113665); Model Catalog: BEQ-HQV 46900 (Lot serial: 92119672); Model Catalog: BEQ-HQV 46900 (Lot serial: 92118001); Model Catalog: BEQ-HQV 46900 (Lot serial: 92109788); Model Catalog: BEQ-HQV 46900 (Lot serial: 92115723); Model Catalog: BEQ-HQV 46900 (Lot serial: 92110183); Model Catalog: BEQ-HQV 46900 (Lot serial: 92116526); Model Catalog: BO-HQV 59204 (Lot serial: 92115322); Model Catalog: BO-HQV 59203 (Lot serial: 92115322); Model Catalog: BO-HQV 47906 (Lot serial: 92115322); Model Catalog: BO-HQV 46901 (Lot serial: 92115322); Model Catalog: BO-HQV 66606 (Lot serial: 92117616); Model Catalo
  • Description du dispositif
    HEART LUNG PERFUSION PACK WITH SOFTLINE
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    HC