Events

Notificaciones De Seguridad De Campo acerca de Dialog Dialysis Machines

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 B Braun.

¿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
    2016-06-21
  • 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
    We became aware that a limited number of flanges assembled into bicarbonate and end conductivity cells showed hairline cracks. these flanges have been limited to three batches manufactured by our supplier. this issue affects the above mentioned dialog+ machines and dialog+/dialog/dialog advanced machines where potentially affected conductivity sensors have been exchanged. if such hairline crack occurs, this can potentially lead to a leakage which might result in a balance deviation. the kind of the potential balance deviation depends on whether a dialog machine is equipped with dialysis fluid (df) filter(s) or not. .

Device

Dialog Dialysis Machines

Manufacturer

B Braun