Events

Avis De Sécurité sur Heater Cooler 1T and Heater Cooler 3T

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par SORIN GROUP DEUTSCHLAND GMBH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always according to our instructions for use. without vigilant performance of the maintenance procedures per the instructions for use, organisms can multiply in a heater cooler device and potentially form biofilm. the biofilm provides an opportunity for bacteria, including mycobacteria, to colonize within the device. there is a possibility that bacteria can become aerosolized when the heater cooler device is operated and serve as a source for contamination.

Device

Heater Cooler 1T and Heater Cooler 3T

Manufacturer

SORIN GROUP DEUTSCHLAND GMBH