Events

Rappel de ALARIS PATIENT CARE SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER

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

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
    62679
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2009-07-13
  • 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
    1)occluded tubing may cause medication not to be delivered. 2)misprogrammed infusion caused by ignoring the warning message. 3) specific esd protection circuitry may result in an over or under infusion. 4)certain fluids solidify in the pumping mechanism. 5) iui connector failure when they become corroded or contaminated.

Device

ALARIS PATIENT CARE SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Modèle / numéro de série
    Model Catalog: 8015 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8110 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8650 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8600 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8120 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8300 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8220 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8000APM (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8100LVP (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8210 (Lot serial: MORE THAN 10 SERIAL NUMBERS)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    ALARIS PATIENT CARE SYSTEM-SERVER MODUL
  • Manufacturer
    CARDINAL HEALTH CANADA

Manufacturer

CARDINAL HEALTH CANADA
  • Adresse du fabricant
    VAUGHAN
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    HC