Events

Alerta De Seguridad O Notificaciones De Seguridad para Protect-A-Line extension set

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 Vygon.

¿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
    MDA/2013/056
  • Número del evento
    CON297509
  • Fecha
    2013-07-25
  • Fecha de publicación del evento
    2013-07-25
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297509?tabName=allTabs
  • 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 false occlusion alarms and interruption to therapy. this is due to a new anti-syphon valve supplied with the sets, which has a higher opening pressure and may require adjustment of infusion pump occlusion alarm settings to avoid false occlusion alarms. vygon are validating a further modification to the anti-syphon valves to marginally reduce the required opening pressure and will supply sets incorporating these once verification has been completed.
  • Acción
    Ensure that all members of staff are made aware of the recommended actions in the manufacturer’s Field Safety Notice. As some hospitals may be using both types of anti-syphon valve, be vigilant if you alter your infusion pump occlusion alarm settings for the new valves.  Make sure you do not have the previous design of valve (which operates at a lower opening pressure) on the line. The product codes for these previous devices are: 0832.01R, 0832.04R and 0832.211R.

Device

Protect-A-Line extension set
  • Modelo / Serial
  • Descripción del producto
    Protect-A-Line extension set. Product codes: 0832.01, 0832.04 and 0832.211. NHS Supply Chain codes (England only): FSB128, FSB124 and FSB0146.
  • Manufacturer
    Vygon

Manufacturer

Vygon