Alerta De Seguridad para Arterial and Cardioplegia Monitor for 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 Corporation.

¿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
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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 arterial and cardioplegia monitor for sarns modular perfusion system 8000 medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs), has initiated a field safety corrective action concerning the arterial and cardioplegia monitors for sarns modular perfusion system 8000. terumo cvs has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular perfusion system 8000. the malfunctions can be broadly categorized as follows: monitor power malfunctions inability to measure pressure inaccurate pressure readings and/or false pressure alarms terumo cvs’ initial investigation has determined that while the operator’s manual for the sarns system 8000 provides instruction on how to respond to the malfunctions, the manufacturer believes the instruction can be clarified for responding to false alarms. there are no known reports of patient injury as a result of these issues. furthermore, the manufacturer is notifying all affecteds users of the possibility of malfunction and reminding them to review the appropriate sections of the operator’s manual, and providing an addendum to the operator’s manual to clarify instruction on how to respond to a false alarm. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 2 november 2012.

Device

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

Manufacturer