Events

Alerta De Seguridad para Advanced Perfusion System 1, Electronic Patient Gas 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_20120703e.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, electronic patient gas system medical device manufacturer, terumo® cardiovascular systems (cvs) corporations, has issued an urgent field safety notice concerning terumo® advanced perfusion system 1. the manufacturer has received reports of two instances where users were confused about the proper adjustment of the local control knobs of the electronic patient gas system on the terumo® advanced perfusion system 1. their investigation revealed that the issue resulted from insufficient labeling on the local control knobs of the electronic patient gas system and a lack of sufficient information in the terumo system 1 operators manual. user confusion about adjustment of the local control knobs could result in a delay in detection and correction of incorrect gas composition to the patient. there have been no reports of patient injury as a result of this issue. the manufacturer will provide additional labeling on the terumo system 1 electronic patient gas system local controls and provide more specific instructions in the operators manual through an addendum. 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, Electronic Patient Gas System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Electronic Patient Gas System
  • Manufacturer
    Terumo® Cardiovascular Systems

Manufacturer

Terumo® Cardiovascular Systems