Events

Alerta De Seguridad O Notificaciones De Seguridad para enFlow® IV fluid and blood warmer

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 Vyaire.

¿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
  • Fecha
    2019-03-19
  • Fecha de publicación del evento
    2019-03-19
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/enflow-iv-fluid-and-blood-warmer-risk-of-unsafe-levels-of-aluminium-leaching-from-the-device-updated-safety-advice-from-manufacturer-mda-2019-016
  • 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
    This MDA replaces MDA/2019/015.The manufacturer has provided MHRA with additional evidence that suggests using the enFlow system with lactated Ringer’s, platelets, plasma, whole blood, packed red blood cells and Sterofundin may lead to a risk of administering potentially harmful concentrations of aluminium.
    Following comprehensive and continuing investigation by MHRA, we recommend measures are put in place to source alternative fluid warming devices as soon as possible. If no alternative devices are available in the short term, overriding clinical need for fluid warming should take precedence over considerations of risk of aluminum release.
    MHRA continues to investigate whether other devices on the market also release higher than recommended levels of aluminium and will take action where necessary.
  • Causa
    Manufactured by vyaire – cartridges with an aluminium warming plate in the fluid pathway can lead to an iv infusion containing aluminium above currently recommended safe levels.
  • Acción
    Use an alternative fluid warming device if available. If alternatives are available, follow the instructions in the manufacturer’s updated Field Safety Notice. In the short term, if no alternative is available, carry out and document a local risk assessment based on a clinical risk-benefit analysis before using this fluid warmer. Overriding clinical need for fluid warming should take precedence over considerations of risk of aluminum release. Put measures in place to source alternative fluid warming systems. Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

enFlow® IV fluid and blood warmer
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Descripción del producto
    The intended use of the enFlow IV Fluid/Blood Warming System is for warming blood, blood products and intravenous solutions prior to administration. It is designed to be used by healthcare professionals in the hospital, clinical and field environments to help prevent hypothermia. The system consists of the enFlow heating system and the disposable cartridge.Description Manufacturers reference NHS Supply Chain reference Blood and fluid warming unit 980105VS FSB1143 Blood and fluid warming disposable cartridges 980200EU FSB1143 Blood and fluid warming disposable cartridges with extension (30) 980202EU FSB1143
  • Manufacturer
    Vyaire

Manufacturer

Vyaire
  • Dirección del fabricante
    Vyaire Medical 26125 North Riverwoods Blvd. Mettawa 60045 USATelephone +1 833 327 3284Email Bob.Arnott@vyaire.com
  • Empresa matriz del fabricante (2017)
    Vyaire Holding Company
  • Source
    MHRA