Alerta De Seguridad para Central for continuous renal replacement therapy FAD 100, ANVISA registration no. 10008530410.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laboratorios B. Braun S.A.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    B. Braun Labs are researching these performance variations. The Unit of Technovigilance - UTVIG / NUVIG / ANVISA is monitoring the actions of the company.
  • Causa
    Laboratories b. braun s / a informs about the imprecision of the equipment in relation to the ultrafiltration parameter to have a volume removal profile higher than the one programmed. when operating in ultrafiltration therapy with dialysate flow rate above 1000 ml / h and an ultrafiltration coefficient dialyser (cuf) greater than 6 ml / mmhg / h, the machine may have a greater volume withdrawal profile than programmed.
  • Acción
    B. Braun sent a letter to all its customers, determining the implementation of the following protocols: 1. Any use of the FAD 100 ® should always be accompanied by continuous supervision (medical and / or nursing) by the user; 2. The patient should be continuously monitored, especially for excessive fluid loss and, if necessary, as required by medical advice, to perform replacement therapy; 3. Preferably work on the dialysate flow rate from 500 ml / h to 1000 ml / hr. For larger flow rates, both the therapy and the patient should be monitored; 4. Use only dialysers with ultrafiltration coefficient less than 6ml / mmHg / h.


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