Events

Alerta De Seguridad para Alaris System Syringe Module

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
    2015-08-25
  • Fecha de publicación del evento
    2015-08-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150825.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 system syringe module the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning alaris system syringe module, manufactured by carefusion. the affected model number is 8110 and material number is 10930269. according to the alert, the manufacturer has received service reports of a channel error on the alaris system syringe module model 8110. a channel error is displayed on the syringe module in association with an audible and visual alarm on the attached point of care unit (pcu) (error code 351.6740); once cleared on the pcu the syringe module remains unresponsive to key presses. this error could occur during an infusion causing an interruption of infusion. whilst connected to an alaris system pcu at the time of error, upon power down and reattachment to any other module the pcu will continue to function as expected, there is no fault or flow on effect to the pcu module. the manufacturer will adjust the syringe drive train assembly on the affected units and replace, if required. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00767-1 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 25 august 2015.

Device

Alaris System Syringe Module
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: CareFusion Alaris System Syringe Module
  • Manufacturer
    CareFusion

Manufacturer

CareFusion