Events

Alerta De Seguridad O Notificaciones De Seguridad para Alaris® SmartSite® needle-free valve

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 CareFusion.

¿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/2014/017
  • Número del evento
    CON418455
  • Fecha
    2014-05-21
  • Fecha de publicación del evento
    2014-05-21
  • 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/CON418455?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 disconnection or inability to disconnect from the smartsite could result in delay to treatment due to: air entering the fluid path replacement of a central catheter or picc under-delivery and leakage of medication. carefusion issued a field safety notice (fsn) in february 2014 providing advice on this problem.
  • Acción
    Quarantine affected lot numbers of SmartSite as listed in the Field Safety Notice. Follow instructions in the FSN including returning verification form to CareFusion. Ensure all users are aware of manufacturer’s Field Safety Notice Arrange for replacement devices.

Device

Alaris® SmartSite® needle-free valve
  • Modelo / Serial
  • Descripción del producto
    Alaris® SmartSite® needle-free valve Product reference: 2000E7D Specific lot numbers The Smartsite is a needle-free IV access device. Affected devices are made from a polycarbonate material. The affected lot numbers are: 13086202, 13086263, 13086309, 13095185, 13095913, 13095914, 13096487, 13096488, 13096489, 13105366, 13105478, 13106563, 13106710, 13106711, 13115316. If relevant to you, the national supply codes are as follows: England NPC: FSW165 Scotland SKU: 066032 Northern Ireland BSO: does not have a PALS reference number Wales NSV: FSN342 Only product code 2000E7D is affected and other configurations or item numbers are not affected. This Medical Device Alert does not affect CareFusion’s MaxPlus or MaxZero needle-free connectors.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion