Events

Notificaciones De Seguridad De Campo acerca de D-Vapor/ D-Vapor 3000

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 Dragerwerk AG & Co. KGaA.

¿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
    As part of our continued market and product monitoring we have become aware of isolated cases in which the unwanted release of evaporating agent was observed by users at the end of the filling procedure. the release may lead to spraying of aerosol into face and eyes of the operator. eye contact with volatile anesthetics can result in serious irritation; immediate flushing of eyes and consultation of a physician is recommended. recently updated material safety data sheets (msds) of desflurane manufacturers recommend the wearing of safety glasses when handling these substances. drager has identified two potential root causes for the reported issues of unwanted release of evaporating agent after filling: a — non-observance of the correct filling procedure, especially with regard to the 2 to 3 seconds pause before bottle removal after filling b — high friction of the drug bottle valve inside the vaporizer opening may delay closing of the bottle valve after filling.

Device

D-Vapor/ D-Vapor 3000

Manufacturer

Dragerwerk AG & Co. KGaA