Events

Rappel de HL 30 PERFUSION SYSTEM - MAIN UNIT

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
    33350
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-02-05
  • 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
    Maquet cardiopulmonary (mcp) has identified two potential issues with the hl30 device which will be addressed in a software upgrade. first in rare instances as a result of an accidental impact or "bump" to the pump head cover the unit may stop. this stoppage is intended to occur by design whenever the pump head cover is opened during operation. however if it occurs due to a rapid impact the unit may stop without an informational message explaining the reason for the stoppage. thus while it is apparent to the user that a stoppage occurred the user is unaware as to the reason. secondly maquet is addressing a software anomaly in the cardioplegia module whereby in a limited number of cases the unit slave pump did not engage after cardioplegia pause. maquet has eliminated the cause of this anomaly.

Device

HL 30 PERFUSION SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: HL 30 (Lot serial: 14031043); Model Catalog: HL 30 (Lot serial: 100033); Model Catalog: HL 30 (Lot serial: 100036); Model Catalog: HL 30 (Lot serial: 100038); Model Catalog: HL 30 (Lot serial: 14031007); Model Catalog: HL 30 (Lot serial: 14031010)
  • Description du dispositif
    HL 30 PERFUSION SYSTEM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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