Events

Rappel de CWP 60 SYSTEM (CENTRAL WATER TREATMENT SYSTEM FOR HEMODIALYSIS)

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
    71414
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-11-21
  • 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 corporation is issuing a device correction for specific models of the central water plant (cwp) reverse osmosis units in order to correct the insufficient crimping of the cables within the main pump. the issue was identified as a result of customer complaints received for the presence of smoke in the water treatment room due to the overheating of the pump in the cwp. as part of baxter's investigation based on pictures provided from the event the most likely cause of the thermal event was due to the crimp of the cables for the main pump being insufficient. to minimize any potential side effects of thermal events please ensure all panels of the cwp are in place.

Device

CWP 60 SYSTEM (CENTRAL WATER TREATMENT SYSTEM FOR HEMODIALYSIS)
  • Modèle / numéro de série
    Model Catalog: WRO63 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 106H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 104S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO112 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO113 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO111 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO101H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO104H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 106S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO101S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103H(P) (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102H(P) (Lot serial: > 100 numbers contact m
  • Description du dispositif
    Central Water Plant Reverse Osmosis Unit (CWP 60);Central Water Plant Reverse Osmosis Unit (CWP 100)
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION