Events

Rappel de PERMANENT LIFE SUPPORT SET

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
    54480
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-12-07
  • 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
    In december 2014 maquet cardiopulmonary notified you via dyr 91 (fsn 2014-12-11) of the increased incidence of blood leakage from the gas outlet connector of the quadrox-id adult and small adult products including the hls and pls sets that contain related oxygenators of this product family. the increased leakage was due to a separation of a small number of the internal fibers from the polyurethane casting in the oxygenator. this separation resulted in the blood leakage that was the subject of the field safety notice. since the release of this notification we have been able to confirm the possible root cause that was described in the notification. additionally we have implemented and validated the necessary corrections that return the products to their original performance specifications. the correction necessary was the implementation of additional process controls during the production process of these fibers at our raw material supplier. the fibers produced under these increased process controls have now been delivered to maquet cardiopulmonary and used on the production of the finished oxygenator products.

Device

PERMANENT LIFE SUPPORT SET
  • Modèle / numéro de série
    Model Catalog: BE-PLS 2050 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-PLS 2051 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-HLS 5050 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-HLS 7050 (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HQV 52305 (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HQV 52302 (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HQV 52306 (Lot serial: > 10 numbers contact mfg); Model Catalog: HMOD 70000-USA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HLS 7050-CA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HLS 5050-CA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HMOD 70000-USA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HMOD 70000 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-HMOD 70000 (Lot serial: > 10 numbers contact mfg)
  • Description du dispositif
    PERMANENT LIFE SUPPORT SET
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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