Events

Alerta De Seguridad para Sarns Modular Perfusion System 8000

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

¿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
    2012-11-02
  • Fecha de publicación del evento
    2012-11-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121102a.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: terumo sarns modular perfusion system 8000 medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs) has initiated a field safety corrective action concerning sarns modular perfusion system 8000. terumo cvs has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the sarns modular perfusion system 8000. very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. the malfunctions can be broadly categorized as loss of wall (ac) power, battery back-up malfunction and battery status indicator malfunction. terumo cvs’ initial investigation found that the operator's manual for the sarns system 8000 does not provide sufficient instruction on how to respond to a flashing red indicator light and how to ensure the function of the battery back-up prior to each case. there were no known reports of patient injury as a result of these issues. the manufacturer is informing sarns system 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user with additional instructions. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 2 november 2012.

Device

Sarns Modular Perfusion System 8000
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo Sarns Modular Perfusion System 8000
  • Manufacturer
    Terumo Cardiovascular Systems

Manufacturer

Terumo Cardiovascular Systems