Events

Alerta De Seguridad para Sarns™ Modular Perfusion System 8000: Cardioplegia Monitor

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

¿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
    2011-09-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110907.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
    Field safety notice: sarns™ modular perfusion system 8000: cardioplegia monitor terumo has issued an urgent medical device correction on sarns™ modular perfusion system 8000: cardioplegia monitor, a device that displays a various parameters including cardioplegia volume tracking. according to the manufacturer, only certain serial numbers are affected by this safety alert. the manufacturer has received 12 reports that captioned device fails to track the cardioplegia delivery volume as needed due to the loss of communication between the monitor and the cardioplegia pump. the manufacturer revealed that the immediate and long term effects of this failure are minimal and there has been no report of patient injury as result of this issue. to correct the issue, terumo will replace the software on all monitors in the affected devices. affected customer will be contacted and the correction action will be completed within 12 months. >according to the local supplier, hong kong does not bare devices with the affected serial numbers. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Sarns™ Modular Perfusion System 8000: Cardioplegia Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Sarns™ Modular Perfusion System 8000
  • Manufacturer
    Terumo

Manufacturer

Terumo