Alerta De Seguridad para LIFE 18 apheresis system

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

¿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
    2014-01-22
  • Fecha de publicación del evento
    2014-01-22
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: miltenyi biotec life 18 apheresis system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning life 18 apheresis system, manufactured by miltenyi biotec. tests in laboratory have shown the possibility that under certain circumstances the life 18 apheresis unit will not interrupt the treatment and stop all pumps if a blood leak occurs in the tubing of the disk separator. according to the manufacturer, this type of a severe blood leak in the fluid path of the disk separator during a treatment has been observed for the first time in more than 30.000 treatments performed with the separator. the manufacturer is developing revised software which will be able to correct the gap in the blood leak detection of the life 18 apheresis unit. as an intermediate preventive action, the manufacturer advises users of the followings: make sure that the patient connected with the life 18 apheresis unit never remains unattended during the treatment. check for tubing set integrity regularly during the treatment. when the blood leak is detected, users should stop the treatment and replace the defective separator. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con362398 if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 january 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Miltenyi Biotec LIFE 18 apheresis system
  • Manufacturer

Manufacturer