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
    2012-03-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120322a.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®advanced perfusion system 1 medical device manufacturer, terumo cardiovascular systems, has issued a field safety notice concerning the 6” roller pump for the terumo® advanced perfusion system 1. terumo cvs has received reports of instances in which the 6” roller pump for the terumo® advanced perfusion system 1 displayed a pump jam message and stopped while in use. in the event of a stop on any pump, a pump stop creates user distraction while the user intervenes to adjust the tubing and/or occlusion setting in order to restart the pump. according to the local supplier, the affected device is not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Corporation