Events

Alerta De Seguridad O Notificaciones De Seguridad para Diacap® Ultra dialysis fluid filter

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por B. Braun Avitum AG.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/033
  • Número del evento
    CON272262
  • Fecha
    2013-05-10
  • Fecha de publicación del evento
    2013-05-10
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272262?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of a gradual increased fluid removal, which may cause symptoms of hypotension during dialysis treatment. ultrafiltration deviations may not be immediately detected by the machine. this is due to a decrease in the residual moisture of the filter membrane, which can cause a higher fluid removal from the patient than initially selected. it has been noted that over time the residual moisture of the membrane used in the diacap ultra dialysis fluid filter decreases leading to an alteration in the membrane permeability, which in turn affects the device flow resistance. when used clinically, the altered functionality of the device can lead to excess fluid of up to 230 ml/hr, being removed under worst case conditions. although the haemodialysis system will alarm at a set value beyond the pre-set ultrafiltration rate, the higher ultrafiltration rate has the potential to cause symptoms of hypotension in some patients.
  • Acción
    Identify quarantine and do not use affected devices. Ensure that all staff are aware of the manufacturer’s Field Safety Notice (FSN) dated 22 February 2013. Develop a system to ensure that these devices are not used more than 10 months from the date of manufacture, until the manufacturer advises otherwise. Return the ‘confirmation of receipt’ form in the FSN to the manufacturer. Contact B. Braun Medical Ltd, Sheffield to arrange replacement of affected product.

Device

Diacap® Ultra dialysis fluid filter
  • Modelo / Serial
  • Descripción del producto
    Diacap® Ultra dialysis fluid filter. Product code: 7107366. All devices that are more than 10 months from the date of manufacture are affected. This device is used as a bacteria and pyrogen filter for dialysis fluid purification, as well as for processing substitution solution for online haemodiafiltration and haemofiltration procedures. The date on the label is in the format YYYY-MM e.g. 2012-07 for July 2012. The month of manufacture in this case is July 2012 which should be counted as month one when calculating the age of filters. Therefore, product manufactured in July 2012 should not be used after April 2013. See Field Safety Notice for further information.
  • Manufacturer
    B. Braun Avitum AG

Manufacturer

B. Braun Avitum AG