Events

Rappel de SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP

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
    22884
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2017-07-19
  • 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
    Manufacturer has determined that condensation in the drain line tubing may lead to a false blood detection alarm activating when no blood is present. also liquid spills such as saline can create bridges of resistance between the circuit components causing the circuit not to function as intended. this can impact initiation or continuation of therapy.

Device

SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP
  • Modèle / numéro de série
    Model Catalog: 0998-00-0446-XX (Lot serial: S806023-D2); Model Catalog: 0998-00-0446-XX (Lot serial: S803570-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803551-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803492-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803634-C0); Model Catalog: 0998-00-0446-XX (Lot serial: S804566-L0); Model Catalog: 0998-00-0446-XX (Lot serial: S81995-A9); Model Catalog: 0998-00-0446-XX (Lot serial: S803567-B0); Model Catalog: 0998-00-3013-XX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 0998-00-0446-XX (Lot serial: S803785-E0); Model Catalog: 0998-00-0446-XX (Lot serial: S803639-C0); Model Catalog: 0998-00-0479-XX (Lot serial: S806816-A3); Model Catalog: 0998-00-0479-XX (Lot serial: S806811-A3); Model Catalog: 0998-00-0479-XX (Lot serial: S805908-B2); Model Catalog: 0998-00-0479-XX (Lot serial: S805907-B2); Model Catalog: 0998-00-0479-XX (Lot serial: S81212-H8); Model Catalog: 0998-00-0479-XX (Lot serial: S804785-B1); Model Catalog: 0998-00-3023-53 (Lot serial:
  • Description du dispositif
    SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP;CS100 INTRA AORTIC BALLOON PUMP;SYSTEM 98XT INTRA AORTIC BALLOON PUMP;CS300 INTRA AORTIC BALLOON PUMP SYSTEM - MAIN UNIT
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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