Events

Alerta De Seguridad O Notificaciones De Seguridad para Mains power lead used with Omnifuse syringe pumps (all models)

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 Smiths Medical International Ltd.

¿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/2014/044
  • Número del evento
    CON478823
  • Fecha
    2014-11-26
  • Fecha de publicación del evento
    2014-11-26
  • 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/CON478823?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 interruption or delay in therapy due to incorrect design of the mains lead supplied by smiths medical. smiths medical ltd has issued a field safety notice (fsn), dated november 2014, to its customers recalling affected products but hasn’t had enough replies to know that users have received and acted on this information. the original fsn was sent in september 2014.  the manufacturer recently identified that more customers were affected and so has issued this second fsn. these 2 fsns provide the same information.
  • Acción
    Ensure all personnel using these devices are aware of this FSN. Quarantine affected leads. Use an alternative pump, where available until a replacement lead is obtained. Fill in the confirmation form in the FSN and return it to the manufacturer by fax on 01582 430 001 or by  email to ukcs@smiths-medical.com

Device

Mains power lead used with Omnifuse syringe pumps (all models)
  • Modelo / Serial
  • Descripción del producto
    Mains power lead used with Omnifuse syringe pumps (all models). Part number 0151-0651.
  • Manufacturer
    Smiths Medical International Ltd

Manufacturer

Smiths Medical International Ltd