Events

Notificaciones De Seguridad De Campo acerca de Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx

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

¿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(08)
  • Fecha
    2014-02-27
  • 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=/applix-smart-applix-vision-nutrition-pumps-serial-numbers-from-1998xxxx-to-2010xxx&id=dd77f825-9782-6eee-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
    Fresenius kabi received an increasing number of complaints from the market about non-detected occlusions. as one possible influencing factor, a defective ball bearing was identified, potentially leading to a shift in the flow rate calibration values. fresenius kabi has been unable to locate all affected pumps that require an upgrade.
  • Acción
    The IMB advises that users:  (1) The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation, including those who maintain pumps and to any other persons/organisations where these devices have been transferred.  (2) Identify the location of all affected pumps.  (3) If you / your institution have any affected pumps, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and contact Fresenius Kabi.

Device

Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx
  • Modelo / Serial
  • Descripción del producto
    Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx
  • Manufacturer
    Fresenius Kabi Limited

Manufacturer

Fresenius Kabi Limited