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.

¿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
    2014-06-20
  • Fecha de publicación del evento
    2014-06-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140620.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, has issued a field safety notice concerning advanced perfusion system 1 with the following details: catalogue no.: 801763 (base for terumo advanced perfusion system 1, 100/120v); 801764 (base for terumo advanced perfusion system 1, 220/240v) serial no.: all dates of distribution: 23 aug 2002 through current through internal assessment, the manufacturer has identified opportunities to improve patient safety by clarifying instructions in the operators manual for the terumo advanced perfusion system 1. updates to the operators manual will make the directions easier to follow and provide more accurate performance ranges that align with device operation. the manufacturer is providing updated instructions to four sections of the operators manual, as the following addenda: terumo advanced perfusion system 1 pressure module terumo advanced perfusion system 1 automatic pump direction change terumo advanced perfusion system 1 centrifugal control unit terumo advanced perfusion system 1 modules according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 jun 2014.

Device

advanced perfusion system 1
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo Advanced Perfusion System 1
  • Manufacturer
    Terumo

Manufacturer

Terumo