Events

Alerta De Seguridad para Advanced Perfusion System 1, Centrifugal 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.

¿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_20120703a.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, centrifugal system 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 multiple reports since september 2008 of various malfunctions of the sarns™ centrifugal system for the terumo® advanced perfusion system 1 in which the user was unable to achieve or maintain the desired flow rate. their investigation revealed that a number of root causes contributed to the failures. the probability of the malfunction occurring in the affected population is rare – less than 0.00318% of uses. the manufacturer is creating an addendum to the operator's manual for the terumo system 1 centrifugal system which includes the following: updates the instructions for responding to drive motor failure. reinforces the recommendation to have back-up equipment for the centrifugal system available during cardiopulmonary bypass. recommends that users consider the use of a one-way valve to prevent retrograde flow in the arterial line of the cardiopulmonary bypass circuit. 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, Centrifugal System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Centrifugal System
  • Manufacturer
    Terumo® Cardiovascular Systems

Manufacturer

Terumo® Cardiovascular Systems