Events

Alerta De Seguridad para Blood Line for Transporting Blood in Hemodialysis Therapy - Record nº 80136990453 - lot: 13C09934

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
    1394
  • Fecha
    2014-06-13
  • 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
    According to the manifestation of the company, the connection problem can cause a leak and, consequently, cause blood loss during therapy.
  • Causa
    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.
  • Acción
    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