Events

Alerta De Seguridad para Maquet Venous Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous Bubble Trap VBT 160

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Maquet Cardiopulmonary AG.

¿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
    2014-08-19
  • Fecha de publicación del evento
    2014-08-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140819.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: maquet venous bubble trap vbt 160 and custom tubing sets containing the venous bubble trap vbt 160 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning bubble trap vbt 160 and custom tubing sets containing the venous bubble trap vbt 160 manufactured by maquet cardiopulmonary ag. the following products are affected: venous bubble trap; vbt 160 (sterile single product) venous bubble trap; vbt 160 u (unsterile single product) custom tubing sets containing the vbi 160: bejbeo-vbt (bioline coating) custom tubing sets containing the vbt 160: bo-vbt (softlinf coating) the manufacturer received complaints from several customers who reported that during use, the venous bubble trap (vbt) draws air into the system. internal investigation by the manufacturer confirmed the customer reports and it was determined that a manufacturing defect in the production of the bubble trap is responsible for the intrusion of air into the system during use. as the main function of the vbt is to remove air from the system during use, the manufacturer considers this defect to present an unacceptable increased level of risk for the patient. if unaddressed, this could result in air entering the circulatory system of the patient and causing severe injury and the possibility of death. the manufacturer has received no reports that the defect present in the vbt has resulted in a serious injury or death to any patient. users of the affected products were advised to take the actions mentioned in the fsn. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/home/groups/fsn/documents/fieldsafetynotice/con445987.Pdf if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 august 2014.

Device

Maquet Venous Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous Bubble Trap VBT 160
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Maquet Venous Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous Bubble Trap VBT 160
  • Manufacturer
    Maquet Cardiopulmonary AG

Manufacturer

Maquet Cardiopulmonary AG