Events

Safety Alert for Hemodialysis Machine, Dialog + and Dialog + HDF models online (7102005, 7102072, 710200C and 710207E), registration 80136990498, risk class III, various series (SEE ANNEX).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A. Endereço; B. Braun Avitum AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1825
  • Date
    2016-02-15
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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