Events

Rappel de ALARIS 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 CAREFUSION 303 INC..

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
    46187
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-07-11
  • 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
    A potential risk has been identified that is associated with the power supply board used with the alaris pc unit model 8015 manufactured after january 2011. a component (u21) on this power supply board is causing an error code (120.4630) "system error" or "missing battery error" at start up. when the 120.4630 "system error" code or "missing battery error" error code is observed this could cause a potential delay of therapy at start up or if observed while infusing the inability to make programming changes to current infusions which may result in serious injury and /or death. during infusion the buttons on the channel operate as expected. this error code has not been confirmed to occur during infusion.

Device

ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Modèle / numéro de série
    Model Catalog: 8015 (Lot serial: Contact manufacturer.); Model Catalog: 8015 (Lot serial: >10 serial numbers.)
  • Description du dispositif
    Alaris PC Unit model 8015
  • Manufacturer
    CAREFUSION 303 INC.

Manufacturer

CAREFUSION 303 INC.