Events

Alerta De Seguridad para Heater-Cooler Devices

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
    2016-06-14
  • Fecha de publicación del evento
    2016-06-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160614.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 heater-cooler devices medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs), has issued a medical device safety alert concerning its heater-cooler devices. the affected devices are identified as follows:- a) sams tcm ii cooling and heating systems [catalog number: 4416, 164935, 164940] b) sams dual cooler-heaters [catalog number: 4332, 14114, 13460] the manufacturer is notifying all users of its heater-cooler devices that the distributor, intercon chemical company, no longer sells the intechlor sanitizer (product code 205) referenced in its heater-cooler cleaning instructions. however, the identical sanitizer is available from other sources. updated instructions on how to source a sanitizer are provided by the manufacturer. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 june 2016.

Device

Heater-Cooler Devices

Manufacturer

Terumo Cardiovascular Systems Corporation