Events

Rappel de ENTERALITE INFINITY ENTERAL FEEDING PUMP

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MAQUET-DYNAMED 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
    27891
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-10-29
  • 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
    The pump uses an optical sensor to detect the presence of fluid or air in the administration set which is why at the completion of a feeding it is expected that the pump will alarm as outlined above. however residual clumps from certain types of feeding preparations may be interpreted by the sensor as food remaining in the administration set causing the pump to continue to run despite the bag being empty. this situation likely occurs with home blended or prepared food as well as non-traditional additives such as fortifiers lipids proteins etc. if the sensor is obstructed by sticky solids it may cause the pump to continue running and cause an overrun failure and may potentially deliver air to the users.

Device

ENTERALITE INFINITY ENTERAL FEEDING PUMP
  • Modèle / numéro de série
    Model Catalog: INFKIT2 (Lot serial: >1000 numbers contact mfg")
  • Description du dispositif
    ENTERALITE INFINITY FEEDING PUMPS
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    HC