Alerta De Seguridad O Notificaciones De Seguridad para Perfusor Space infusion pump

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom 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
    Safety alert / Field Safety Notice
  • ID del evento
  • Número del evento
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of interruption of therapy when changing syringe. if an aged battery (4 years or older) is used, the pump may not have sufficient power to perform a syringe change, despite the battery indicator on the pump showing a full charge. this could lead to the therapy unexpectedly stopping. the problem does not arise if the pump is plugged into the mains electrical supply. please see the manufacturer’s field safety notices (technical or clinical).
  • Acción
    Ensure all relevant staff are aware of the problem and of the guidance in the Field Safety Notice. Identify and replace or test any batteries that are 4 years or older as detailed in the service manual. During transportation of patients: Do not use a pump with aged batteries, if possible. In all cases make sure a spare battery or pump is available, as detailed in the user manual. Actions by All those responsible for the use or maintenance of the devices.


  • Modelo / Serial
  • Descripción del producto
    Perfusor Space infusion pump. The service manual , page 6-3, provides guidance on the identification of pumps with affected batteries.
  • Manufacturer