Events

Notificaciones De Seguridad De Campo acerca de Heater Cooler 1T and Heater Cooler 3T

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por SORIN GROUP DEUTSCHLAND GMBH.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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