Alerta De Seguridad para Hemodialysis Device DBB-06 and DBB-07

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

¿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
    2012-10-17
  • Fecha de publicación del evento
    2012-10-17
  • 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: nikkiso hemodialysis device dbb-06 and dbb-07 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning hemodialysis device dbb-06 and dbb-07 [ref. no.: ge-f110-00, ge-f111-00, ge-f112-00, ge-f114-00 and ge-f115-00]. the date of manufacturing of the affected products were september 2012 and before nikkiso has received two complaints from a hospital technical department regarding too high a patient leakage current with the dbb-06 devices, used in combination with a central venous catheter (cvc). the current is normally taken to ground via the earth conductor in the mains cable; however if the conductor is compromised the current will pass through the dialysate lines and dialyser to the central venous catheter and then to ground via any earthed surface the patient touches. therefore, if the patient leakage current exceeds the recommendation of 10μa for type cf applied parts with a direct cardiac application there is a risk that the current could become concentrated at the catheter tip and could exceed the level that would induce ventricular fibrillation. models dbb-06 and dbb-07 have a patient leakage current higher than that specified for type cf applied parts. apart from the two complaints mentioned above, no incident or complaint related to a too high patient leakage current was filed for both devices. the manufacturer reminded users to consider that dbb-06 and dbb-07 devices may have additional risks in cvc treatment mode. field service engineers of the manufacturer will modify the hardware of the dbb-06 and dbb-07 devices and check the compliance to the new established patient leakage current within the yearly standard preventive maintenance activities. for details, please refer to the mhra website as below: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con189227 if you are in possession of the affected product, please contact your supplier for necessary actions. . posted on 17 october 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: NIKKISO Hemodialysis Device DBB-06 and DBB-07
  • Manufacturer

Manufacturer