Events

Notificaciones De Seguridad De Campo acerca de H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory

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

¿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
    SN2008(02)
  • Fecha
    2008-01-31
  • 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=/h-1200-fast-fluid-warmer-with-integrated-air-detector-clamp-and-h-31b-and-h-30-air-detector-clamp-accessory&id=0594f825-9782-6eee-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 risk of air embolism if the power of the fluid warmer unit is interrupted either manually or through power failure during an air detection event.
  • Acción
    Further to this incident the Irish Medicines Board (IMB) advises users to discontinue the use of the device until further notice.   Identify and quarantine affected devices until further notice.   If no alternative fluid warmer is available, ensure users are aware of the advice provided in the manufacturer’s customer letter (copy attached as appendix 1) and ensure that the quick reference guide is attached to all affected devices.   Contact the manufacturer to request a copy of quick reference guide if not attached to all affected devices

Device

H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / C...
  • Modelo / Serial
  • Descripción del producto
    H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical