Events

Alerta De Seguridad para CDI™ 500 Blood Parameter Monitoring System

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
    2012-03-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120310b.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: terumo cdi™ 500 blood parameter monitoring system medical device manufacturer, terumo cardiovascular systems corporation, has issued a field safety notice concerning cdi™ 500 blood parameter monitoring system. in a recent review of in-house service procedures for the cdi™ 500 blood parameter monitoring system, terumo cardiovascular systems (terumo cvs) determined that replacement of the batteries should be considered “routine maintenance”. currently, system batteries that are 10 years old or older will be replaced by service technicians when a system is sent to terumo cvs for service. the current operator’s manual for the cdi 500 system does not list any routine maintenance procedures for the system. therefore, some systems may be relying on system batteries beyond their useful life. in this case, error codes may appear, and the system is at risk of losing information. there have been no reports of patient injury as a result of this issue. terumo cvs is now revising the operator’s manual for the cdi 500 system to remind operators to replace the system batteries every 10 years. according to the local supplier, affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

CDI™ 500 Blood Parameter Monitoring System

Manufacturer

Terumo Cardiovascular Systems Corporation