Events

Rappel de MIO INFUSION SETS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par INSULINPUMPS.CA 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
    86242
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2017-09-27
  • 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
    Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. the reported incidence rate requiring medical assistance related to thisissue is less than 1 in every 2 million infusion sets. over-delivery of insulin can cause hypoglycemia and in extreme cases death. medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. manufacturer investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. a membrane blocked by fluid may occur if insulin alcohol or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. infusion sets currently being shipped by medtronic contain a new and enhanced membrane material that significantly reduces this risk.

Device

MIO INFUSION SETS
  • Modèle / numéro de série
    Model Catalog: MMT-975600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-965600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-943600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-941600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-921600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-923600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-862 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-866 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-874 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-864 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-398600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-397600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-387600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-386600 (Lot serial: >10 lot numbers contact mfg); Model Catalog: MMT-396600 (Lot serial: >10 lot numbers cont
  • Description du dispositif
    MIO INFUSION SETS
  • Manufacturer
    INSULINPUMPS.CA INC.

Manufacturer

INSULINPUMPS.CA INC.
  • Adresse du fabricant
    OAKVILLE
  • Source
    HC