Alerta De Seguridad para advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion system 9000

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
    2012-06-22
  • Fecha de publicación del evento
    2012-06-22
  • 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 advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion system 9000 medical device manufacturer, terumo cardiovascular systems (cvs) corporations, has issued an urgent field safety notice concerning terumo advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ perfusion system 9000. the manufacturer has received multiple reports of false alarms generated by the air bubble detection system used with perfusion system of the above models. it will possibly result in temporary interruption of arterial blood flow, air entrainment in the system, or the need to continue the case with a disabled air sensor. there have been no reports of patient injury as a result of this failure. their investigation determined that prior corrective actions on the sensor (in 2007 and 2010) did not fully eliminate the possibility for malfunction. therefore, terumo cvs has amended the operator’s manuals for its heart-lung machines to alert all users of the potential for a malfunction of the air bubble detection system and to reinforce the mitigation procedures in the event of a malfunction. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 june 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo Advanced Perfusion System 1, Sarns™ Modular Perfusion System 8000 and Sarns™ Modular Perfusion System 9000
  • Manufacturer

Manufacturer