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
    2012-01-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120112.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
    [13 january 2012] field safety notice: terumo® advanced perfusion system 1 medical device manufacturer, terumo® cardiovascular systems corporation, has issued a field safety notice on the use of unauthorized cable for terumo® advanced perfusion system 1. the manufacturer is aware of some users operating a terumo® advanced perfusion system 1 with a modified cable to connect the system to an occluder for the sarns™ modular perfusion system 8000. the cable is not specified for use with terumo® system 1 and its use in this manner constitutes an off-label use. the modified cable is not compliant with terumo® system 1 specifications and its use may result in hazardous conditions such as easy dislodgement from the system base resulting in loss of the occluder’s function. it may cause the system to lose electro-magnetic interference protection or create a minor shock hazard in the event of an internal short/failure within the occluder system components. according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Corporation