Events

Rappel de Sorin 1T /3T FlexTherm Systems

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 Sorin Group Deutschland GmbH.

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
    20357
  • Date de mise en oeuvre de l'événement
    2016-07-08
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Cause
    The instructions for use for the 1t and 3t/flextherm system prescribe the addition of 50ml and 150ml respectively of medical grade 3% hydrogen peroxide to the filtered tap water in the device, which results in a maximum concentration of approximately 330ppm. the purpose of adding the hydrogen peroxide is to prevent microbial growth between the regular cleaning / disinfection cycles performed every 2 weeks., the manufacturer has determined that plastic heat-exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow for diffusion of some quantity of hydrogen peroxide during a typical procedure.
  • Action
    Manufacturer to issue advice regarding use

Device

Sorin 1T /3T FlexTherm Systems
  • Modèle / numéro de série
    Model: 16-02-50 16-02-80 16-02-91 16-02-82 16-02-83 16-02-85 16-02-95 and 16-70-00, Affected:
  • Manufacturer
    Sorin Group Deutschland GmbH

Manufacturer

Sorin Group Deutschland GmbH