Events

Rappel de Curlin Medical infusion pump

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 Moog Medical Devices Group 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
    19678
  • Date de mise en oeuvre de l'événement
    2016-01-19
  • 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: Biomed Limited, 52 Carrington Road, Point Chevalier, AUCKLAND
  • Cause
    Master pumps used to calibrate curlin infusion pumps manufactured or serviced from march 18, 2015 to november 6, 2015 were out of tolerance.Use of affected pumps may cause an over-delivery of medications and solutions at a rate of 1.2 – 6.8% faster than programmed. likewise, the volume to be infused may be depleted earlier than expected, resulting in over delivery of overfill contained in the iv bag, if overfill is present. if overfill is not present, the pump may present an air in line or upstream occlusion alarm once the iv bag has emptied. the pump will stop infusing when either of these alarms occurs.
  • Action
    Product to be returned to supplier

Device

Curlin Medical infusion pump

Manufacturer

Moog Medical Devices Group Inc
  • Société-mère du fabricant (2017)
    Moog Inc.
  • Source
    NZMMDSA