Events

Notificaciones De Seguridad De Campo acerca de Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units

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

¿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
    SN2011(05)
  • Fecha
    2011-04-08
  • 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=/level-1-normothermic-iv-fluid-administration-sets-for-use-with-the-level-1-fast-flow-fluid-warmer-units&id=f797f825-9782-6eee-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
    Smiths medical has become aware of an increased trend in reports of kinking of the tubing on certain level 1® normothermic iv fluid administration sets (models di-65hl, di-75 and di-150). in some cases, the kink may lead to a decrease in the flow of fluid to the patient. a reduction in flow rate may lead to a delay of therapy, which could result in patient injury.
  • Acción
    The Irish Medicines Board advises users of this product to inspect their inventory and segregate the affected products for return to the manufacturer as per the attached field safety notice.  Users should exercise extreme caution when using the alternative replacement products and remain cognisant of the clinical risks associated with these sets, which are not equipped with the F-50 Gas Vent Filter Assembly.  Users should also take care to:  • Ensure that all Level 1® fast flow fluid warmer units contain a copy of the quick reference guide distributed by Smiths Medical in 2007.  • Contact the manufacturer to request a copy of the quick reference guide if required.

Device

Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warm...
  • Modelo / Serial
  • Descripción del producto
    Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical