Events

Alerta De Seguridad para Ultrafilter U9000

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

¿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
    2014-08-05
  • Fecha de publicación del evento
    2014-08-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140805.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: gambro ultrafilter u9000 medical device manufacturer, gambro, has issued a field safety notice (fsn) concerning its ultrafilter u9000. there is a possibility of external fluid leakage with ultrafilter u9000 as a result of multiple disinfections using a sodium carbonate-based solution. the housing of the ultrafilter u9000 is made of polycarbonate, a material that is known to undergo slow chemical degradation during long term exposure to alkaline substances. intensive use of sodium carbonate-based disinfection programs over several months may, therefore, cause degradation of the ultrafilter housing leading to an external fluid leakage at the position of the welding seal between the filter housing and the header cap. if a leakage is observed during treatment, the user should immediately stop the treatment and change the u9000 ultrafilter to avoid excessive fluid removal from the patient. furthermore, the use of sodium carbonate-based disinfection programmes has been broadly validated for the u9000 ultrafilter. however, to minimize the risk of an external fluid leak, the manufacturer strongly recommends adhering to the instructions mentioned in the fsn, when using sodium carbonate based disinfection programmes with u9000. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 5 aug 2014.

Device

Ultrafilter U9000
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Gambro Ultrafilter U9000
  • Manufacturer
    Gambro

Manufacturer

Gambro