Events

Alerta De Seguridad O Notificaciones De Seguridad para unkown device

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 manufacturer #17429.

¿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/2012/009
  • Número del evento
    CON143805
  • Fecha
    2012-03-01
  • Fecha de publicación del evento
    2012-03-01
  • 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/CON143805?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
    Smiths medical has become aware of an increase in the number of reports of disconnections of the luer lock connector at the patient end of the tubing for these fluid warming sets. this can lead to a risk of fluid/ blood loss or delay in therapy. the mhra cannot be confident that these recalls have been effective and that users have received and acted on the information provided in the manufacturer’s field safety notices (fsns).
  • Acción
    Do not use the affected devices. Contact Smiths Medical to arrange the return and replacement of the affected sets as advised in the two Smiths Medical Field Safety Notices (FSNs) issued on 28 November 2011 for: Level 1® Hotline®         The FSNs list the lot numbers of all affected devices. Send the confirmation return form to Smiths Medical. Action by All those involved in the supply and use of these devices.

Device

unkown device

Manufacturer

manufacturer #17429