Events

Rappel de ARTISET BLOOD TUBING SET FOR HAEMODIALYSIS HD SN HC

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
    63785
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2016-11-30
  • 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 safety alert communication to inform customers of the potential for disconnection of the artiset bloodline (luer of arterial and/or venous patient connector) from the patient access site (needle/catheter) during treatment. baxter has identified a potential for increased likelihood of disconnection during post-market surveillance activities. the arterial and venous patient connectors are designed in compliance with the applicable international standards iso594 and iso8638 allowing safe connection to vascular accesses. the post-market surveillance reports of disconnection of the artiset bloodline from the patient access site were caused by the healthcare provider improperly connecting the two devices. to address this issue baxter is providing additional instructions on how to properly connect the devices.

Device

ARTISET BLOOD TUBING SET FOR HAEMODIALYSIS HD SN HC
  • Modèle / numéro de série
    Model Catalog: 114533 (Lot serial: LOT 1634 AND ONWARDS)
  • Description du dispositif
    Artiset Blood Tubing Set For Haemodialysis HD SN HC
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION