Events

Rappel de MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP

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

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
    63847
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-02-16
  • 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
    Since october 2010 smiths medical has received a total of 4 complaints regarding system errors that cause the medfusion 4000 pump to stop running. there have been no reports of patient injury or death. investigation has identified the root cause to be related to a software anomaly that originated during development that causes a particular history log corruption to occur. further under infrequent circumstances the normal error recovery mechanism for the history corruption (i.E. clear history) is not successful. when the recovery mechanism is not successful the "watchdog fail-safe" alarm is triggered. the combination of the corruption and unsuccessful recovery results in a persistent re-occurrence of the "watchdog fail-safe" on every power-up preventing further use of the pump.

Device

MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP
  • Modèle / numéro de série
    Model Catalog: 4000-0100-50 (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 4000-0101-50 (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 4000-0100-249 (Lot serial: > 10 CONTACT MANUFACTURER)
  • Description du dispositif
    Medfusion 4000 Syringe Pump
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    HC