Events

Notificaciones De Seguridad De Campo acerca de Heater/Cooler Systems

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 MAQUET.

¿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
  • Fecha
    2015-11-30
  • 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
    Maquet cardiopulmonary as well as the national competent authorities in multiple countries have received reports confirming the presence of mycobacterial contamination (and other bacterial contaminants) in the system water of heater and heater/cooler devices. this system water is used in the direct patient warming and or in heat exchangers used to warm the patient blood during surgical procedures (cardiac bypass procedures). maquet cardiopulmonary has confirmed that maquet systems used in these procedures are contaminated with various strains of bacteria that also include mycobacteria species. the exact source of this contamination is unknown.

Device

Heater/Cooler Systems
  • Modelo / Serial
  • Manufacturer
    MAQUET

Manufacturer

MAQUET
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    AMPMDRS