Events

Alerta De Seguridad para Alaris syringe pumps (all models)

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por CareFusion.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-12-23
  • Fecha de publicación del evento
    2016-12-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161223d.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: alaris syringe pumps the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning alaris syringe pumps (all models). alaris syringe pumps are manufactured by carefusion – using non-recommended syringes in alaris syringe pumps that have a broken spring in the plunger assembly may cause unintended bolus of medication. users are advised to: if the pump keeps showing ‘check syringe’ alarms, contact the manufacturer to discuss how to check the springs housed in the plunger holder; use only the recommended syringes listed in the instructions for use for these pumps; ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s recommendations. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/alaris-syringe-pumps-all-models-risk-of-uncontrolled-bolus-of-medicine-with-non-recommended-syringes if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 december 2016.

Device

Alaris syringe pumps (all models)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Alaris Syringe Pumps
  • Manufacturer
    CareFusion

Manufacturer

CareFusion