Events

Alerta De Seguridad para Alaris PC Unit Model 8000

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por CareFusion 303.

¿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
    2012-09-18
  • Fecha de publicación del evento
    2012-09-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120918.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: carefusion alaris pc unit model 8000 the health canada has issued a type i recall concerning alaris pc unit model 8000, manufactured by carefusion 303, inc. according to the health canada, the pc unit model 8000, when used with pump or syringe modules, may under certain conditions display an incorrect total dose when programmed to deliver bolus dose. the pump or syringe module delivers the actual programmed bolus dose (and associated volume to be infused) regardless of the displayed total bolus dose. this can cause confusion leading to improper treatment potentially causing injury or death. according to the local supplier, the affected products were not distributed in hong kong for details, please refer to the following health canada website: for details, please refer to the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_july-sept_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 september 2012.

Device

Alaris PC Unit Model 8000
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: CareFusion Alaris PC Unit Model 8000
  • Manufacturer
    CareFusion 303

Manufacturer

CareFusion 303