Events

Alerta De Seguridad para Level Sensor II Pads

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
    2011-08-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110818.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 removal: terumo level sensor ii pads terumo cardiovascular systems (terumo cvs) issued an urgent product removal of level sensor ii pads. the removal followed an investigation about the reports of level sensor ii pads detaching from the surface of the venous reservoir. the affected products are of an older population that is labeled with a manufacture date but not an expiration date. they were shipped between december 28, 2000 and january 1, 2010. the adhesive is intended for use within two years of the date of manufacture, otherwise it may detach. the detachment of the level sensor pad from the venous reservoir compromises the capabilities of the level detection system, preventing the ultrasonic level sensor from maintaining adequate contact with the reservoir. the risk caused by the detachment of the level sensor pad varies with the type of perfusion system that it is used with. in serious cases, it may cause interruption to blood flow due to unanticipated pump stop, which in turn, may lead to reduction in blood pressure and severe injury. according to the local supplier, there is no record of distribution of the affected product in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Level Sensor II Pads

Manufacturer

Terumo Cardiovascular Systems