Events

Alerta De Seguridad para Hemodialysis Machine, Dialog + and Dialog + HDF models online (7102005, 7102072, 710200C and 710207E), registration 80136990498, risk class III, various series (SEE ANNEX).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laboratórios B. Braun S.A. Endereço; B. Braun Avitum 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
  • ID del evento
    1825
  • Fecha
    2016-02-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    Reinforce the need for users NOT to use the hand-held level regulator in therapy and DO NOT perform any SN / CO single puncture therapy before certifying the perfect operation of the Dialog + SW 9.xx manual level regulator.
  • Causa
    By means of investigations by the registry holder, b. braun s / a, the possibility of reversing the positioning of the tubes between the valve block of the level regulator system and the diaphragm pump was identified. this occurs during any technical intervention or maintenance measures if the functionality of this level regulator system is not properly tested as required in the service manual. this can occur during any repair or maintenance activity where it is necessary to disconnect and reconnect the tubes, which results in reversing the function of the manual level control system.
  • Acción
    Action code AC / 03/2015. Elaboration of Message Letter with Security Alert dated 04/4/2015 and delivery to each client involved //// Receipt of Receipt Confirmations of the Message Letter //// Correction in the field for the applicable cases through Correction of parts.

Device

Hemodialysis Machine, Dialog + and Dialog + HDF models online (7102005, 7102072, 710200C and 7102...

Manufacturer

Laboratórios B. Braun S.A. Endereço; B. Braun Avitum AG