Events

Alerta De Seguridad para Medfusion Model 4000 Syringe Infusion Pump

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

¿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
    2012-08-03
  • Fecha de publicación del evento
    2012-08-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120803.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: smiths medical medfusion model 4000 syringe infusion pump the united states food and drug administration (fda) has issued a class i recall concerning all medfusion model 4000 syringe infusion pumps with software versions v1.0 and v1.1 manufactured by smiths medical asd, inc. according to the fda, systems errors can cause the medfusion 4000 infusion pump to go into an alarm condition and stop running, which can result in a delay or an interruption of patient therapy. for patient receiving critical therapy, a delay or interruption of therapy could result in serious injury and/or death. for details, please refer to fda website http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ ucm314282.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 august 2012.

Device

Medfusion Model 4000 Syringe Infusion Pump

Manufacturer

Smiths Medical ASD