Events

Safety Alert for Central for continuous renal replacement therapy FAD 100, ANVISA registration no. 10008530410.

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

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
    841
  • Date
    2006-10-31
  • 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
    B. Braun Labs are researching these performance variations. The Unit of Technovigilance - UTVIG / NUVIG / ANVISA is monitoring the actions of the company.
  • Reason
    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.
  • Action
    B. Braun sent a letter http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/841.pdf 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.

Device

Central for continuous renal replacement therapy FAD 100, ANVISA registration no. 10008530410.

Manufacturer

Laboratorios B. Braun S.A
  • Source
    ANVSANVISA