Events

Safety Alert for Blood Line for Transporting Blood in Hemodialysis Therapy - Record nº 80136990453 - lot: 13C09934

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.; 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
    1394
  • Date
    2014-06-13
  • 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
    According to the manifestation of the company, the connection problem can cause a leak and, consequently, cause blood loss during therapy.
  • Reason
    The company that holds the registry informs about the possibility of disconnection, during dialysis therapy, of the glued joint between the pump segment and the blood line system. the cause is the lack of bonding of the pump segment that was inserted into the connector during the production process.
  • Action
    The company that holds the registration in Brazil requests the interruption of the distribution of said products / lots that are still in the customer's stock and segregation of the same, as well as the information to Laboratorios B. Braun SA of the quantities of existing units of each product code and lot number.

Device

Blood Line for Transporting Blood in Hemodialysis Therapy - Record nº 80136990453 - lot: 13C09934

Manufacturer

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