Events

Rappel de Sorin S3 Heater Cooler

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
    17069
  • Date de mise en oeuvre de l'événement
    2014-07-30
  • 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
    Newly identified risk for cardiac surgery patients whereby some patients have been infected with a slow growing mycobacterium chimaera. this organism is found in water including tap water sources., important to review hygiene and surgical practices in the cardiac surgery theatre. this review should include sampling and monitoring programs for water sources solution preparations and systems that use water in the cardiac surgery theatre. among these water systems, heater cooler device(s) need strict adherence to the cleaning disinfection and maintenance according to the operator manual for sorin devices.
  • Action
    Manufacturer to issue advice regarding use

Device

Sorin S3 Heater Cooler

Manufacturer

Sorin Group Deutschland GmbH