Events

Rappel de COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAXTER CORPORATION.

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
    17878
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-18
  • 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
    Baxter is notifying users of a range of potential issues that may be observed with colleague p1.5 volumetric infusion pumps. these issues include: occlusion detection sensor failure caused by fluid ingress variations in pump accuracy if a pump is dropped an electric circuit that does not comply with international safety standards an internal communication failure that will result in pump shutdown (see 2008fca18) and various battery maintenance problems (see 2008fca18).

Device

COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP
  • Modèle / numéro de série
    Model Catalog: 2M9161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153KL (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153K (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M9163 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM9161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM 8151R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM 8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8161R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151KL (Lot serial: >1000 NUMBERS CONTACT MFR);
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION