Events

Notificaciones De Seguridad De Campo acerca de Dialyzer

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 Asahi Kasei Medical CO., Ltd.

¿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
    The investigation results showed that there were small breakages on hollow fibers in the returned dialyzers, which caused blood leakage during the dialysis treatment with hemodiafiltration (hdf) mode. note that these leakages occurred later than one hour after start of treatment, which means that such broken hollow fibers would not have existed at the beginning of the treatment. further internal investigation suggested that the broken hollow fibers were originated by the weakness of the hollow fibers to the pressure strength in a small restricted portion.

Device

Dialyzer

Manufacturer

Asahi Kasei Medical CO., Ltd