Events

Alerta De Seguridad para Advanced Perfusion System 1, Central Control Monitor

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
    2012-07-03
  • Fecha de publicación del evento
    2012-07-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120703b.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® advanced perfusion system 1, central control monitor medical device manufacturer, terumo® cardiovascular systems (cvs) corporation, has issued an urgent field safety notice concerning terumo® advanced perfusion system 1. the manufacturer has received reports of the central control monitor (ccm) for terumo advanced perfusion system 1 losing partial or full functionality. symptoms that have been associated with a malfunctioning ccm include: full or partial loss of display; loss of control functions; or an inability to distinguish various status, alert, or alarm conditions. in one report, the ccm emitted smoke. their preliminary investigation found the failures were due to design or supplier workmanship issues. the probability of patient injury caused by this malfunction is low because all the primary functions and controls on the ccm can be maintained through the terumo system 1's local controls. there have been no reports of patient injury as a result of this issue. the manufacturer is providing an addendum to the operator's manual for terumo system 1 with instruction on what to do in the event of a ccm 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 3 july 2012.

Device

Advanced Perfusion System 1, Central Control Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Central Control Monitor
  • Manufacturer
    Terumo® Cardiovascular Systems

Manufacturer

Terumo® Cardiovascular Systems