Events

Notificaciones De Seguridad De Campo acerca de HomeChoice/HomeChoice PRO Automated PD System

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Baxter Healthcare SA.

¿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(11)
  • Fecha
    2014-03-14
  • 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=/homechoice-homechoice-pro-automated-pd-system&id=baccf925-9782-6eee-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
    Baxter healthcare is issuing a field safety notice (fsn) to inform users of the homechoice/homechoice pro systems of an additional warning to be included in the device product labeling. the warning relates to unintended increased intraperitoneal volume (iipv) in specific patient populations using peritoneal dialysis therapy.
  • Acción
    1. Follow the manufacturer’s recommendations in the attached FSN. A copy of the FSN (and warning instructions) should be kept with your HomeChoice user manual. 2. Ensure that relevant personnel, in particular home patients, receive a copy of the attached FSN and are made aware of the information contained in the FSN and additional warning instructions.  3. If you have distributed the devices to other healthcare professionals or organisations, please forward this notice accordingly.

Device

HomeChoice/HomeChoice PRO Automated PD System

Manufacturer

Baxter Healthcare SA