Events

Rappel de GAMBRO AK-200 ULTRA

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
    106558
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-04-19
  • 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
    Baxter has become aware that some users have not followed the start-up procedures when performing online priming with the ak200 ultra s. patients are at risk of receiving priming solution if the start-up procedures for on-line priming described in the operator's manual are not followed when preparing the ak 200 ultra s for a patient treatment. a patient may receive priming solution if the operator/user: fails to properly attach the venous line in the venous clamp during the priming procedure and fails to verify the illumination of the machine blood path indication after patient connection and fails to confirm start of treatment.

Device

GAMBRO AK-200 ULTRA
  • Modèle / numéro de série
    Model Catalog: AK-200 ULTRA S (Lot serial: 12593); Model Catalog: AK-200 ULTRA S (Lot serial: 18143); Model Catalog: AK-200 ULTRA S (Lot serial: 18142); Model Catalog: AK-200 ULTRA S (Lot serial: 15683); Model Catalog: AK-200 ULTRA S (Lot serial: 12591); Model Catalog: AK-200 ULTRA S (Lot serial: 13299); Model Catalog: AK-200 ULTRA S (Lot serial: 19696); Model Catalog: AK-200 ULTRA S (Lot serial: 19695); Model Catalog: AK-200 ULTRA S (Lot serial: 12592); Model Catalog: AK-200 ULTRA S (Lot serial: 15681)
  • Description du dispositif
    AK 200 ULTRA S
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION