Events

Rappel de Electric infusion pump administration set_IIa

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par BD Switzerland Sarl.

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
    23250
  • Date de mise en oeuvre de l'événement
    2018-06-28
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Cause
    The bd alaris infusion pump administration sets require priming prior to use as described in the directions for use (dfu). the manufacturer has identified a potential issue with the bd alaris infusion pump administration sets manufactured during january 2017 through march 2018. the issue pertains to the back check valve and the ability to prime the administration sets. the cause leading to this issue are., 1. excessive solvent used to connect the tubing to the back check valve leading to an obstruction of the fluid path, thus preventing the priming of the set., 2. a higher cracking pressure of the back check valve.
  • Action
    Manufacturer to issue advice regarding use

Device

Electric infusion pump administration set_IIa
  • Modèle / numéro de série
    Model: BD Alaris™ Primary set, 2 SmartSite Y ports, 1 BCV 294cm, BD Alaris™ Primary set, 2 SmartSite Y ports, 1 BCV 294cm, BD Alaris™ Primary set, 3 SmartSite Y ports, 1 BCV 320cm, BD Alaris™ Primary set, 5 SmartSite Y ports, 1 BCV 349cm, Affected:
  • Manufacturer
    BD Switzerland Sarl

Manufacturer

BD Switzerland Sarl