Events

Notificaciones De Seguridad De Campo acerca de BBraun Perfusor Space Infusion Pump

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por B. Braun Melsungen AG.

¿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
  • Número del evento
    SN2014(17)
  • Fecha
    2014-04-08
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/bbraun-perfusor-space-infusion-pump.-priority-2---warning&id=85cff925-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The irish medicines board (imb) wishes to remind users of a field safety notice (fsn) issued by b. braun in december 2013. b. braun has identified a risk that when the perfusor space pump is used with an aged battery, that the pump may not have sufficient current to perform a syringe change, despite the battery indicator on the pump showing full charge.  the issue can only occur when the pump is not connected to the mains and presents a risk when the pump is used on battery only.
  • Acción
    The IMB would like to remind users to:  (1) Follow the instructions outlined by the manufacturer in the FSN attached.  (2) Identify any batteries (or battery packs) of four years or older.  (3) Contact your Biomedical Engineering Department to arrange for replacement or testing of the battery (battery pack), as outlined in the device service manual.  (4) Always have an additional pump available for infusion of critical medications and during transport of patients.  (5) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information.

Device

BBraun Perfusor Space Infusion Pump
  • Modelo / Serial
  • Descripción del producto
    BBraun Perfusor Space Infusion Pump. Priority 2 - Warning
  • Manufacturer
    B. Braun Melsungen AG

Manufacturer

B. Braun Melsungen AG