Events

Alerta De Seguridad para Advanced Perfusion System 1

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
    2012-08-17
  • Fecha de publicación del evento
    2012-08-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120817b.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 medical device manufacturer, terumo cardiovascular systems corporation, has issued a medical device safety alert concerning terumo advanced perfusion system 1. terumo cardiovascular systems (terumo cvs) has received ten reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities using the following modules for the terumo advanced perfusion system 1: serial interface module rs-232 serial interface module rs-485 interface module for cdi system 100/101 interface module for cdi system 500 some reports stated that the odor of smoke was associated with the failures. according to the manufacturer, the malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. terumo cvs' investigation has determined that the malfunctions are caused by a circuit board that failed. based on the information provided by the local supplier, the affected products have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 17 august 2012.

Device

Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Corporation