Events

Alerta De Seguridad para Hemodialysis Machine Technical Name: ANVISA Registration Number: 80136990498 Hazard Class: III Affected Model: Dialog + and Dialog + HDF online (710200C, 7102072, 7105005 and 710500C)

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.; 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
    2181
  • Fecha
    2016-10-21
  • 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
    The mentioned bug has been fixed with Software Version 8.2B. All Dialog + dialysis equipment with 8.2A software and optional Adimea MUST be upgraded to software version 8.2B, so that until all Dialog + devices are upgraded to 8.2B software, the "timer / stop" function must not be used watch "and / or reminders should be monitored independently from the machine. #### Update of the field action: UPDATED ON 11/23/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    A software (sw) error was identified in dialog + dialysis equipment version 8.2a that affects the timer / stop watch timer function. this function serves only as a user support to remind you of an action that should be taken by the user. this fault occurs only in sw 8.2a and only if used in conjunction with the adimea option. under certain conditions, and in rare episodes, the warning triggered to remind the user is restarted / changed by the machine without any human action. the user may be unaware that the notice has been modified.
  • Acción
    Field Action Code AC / 03/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will make correction in the field.

Device

Hemodialysis Machine Technical Name: ANVISA Registration Number: 80136990498 Hazard Class: III Af...

Manufacturer

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