Events

Alerta De Seguridad para Enteromat Compact Infusion Pump, Registration 80136990431 - Number of series A4491, A4493, A4494, A4495, A4496, A4497, A4498, A4499, A4500, A4501, A4S02, A4503, A4504, A450S, A4558, A4559, A4560, A4561, A4562, A4590, A4590, A4590, A4590, A4590, A4590, A4570, A4510, A4590, A4522, A4524, A4523, A4524, A4524, A4524, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A4552, A4553, A4554, A4555, A4556, A4557.

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..

¿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
    1421
  • Fecha
    2014-08-19
  • 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 company's statement, all equipment was 100% evaluated before its release to the market, presenting results in accordance with the specifications defined therein, including calibration, ensuring that they are suitable for use. The company claims that the equipment complies with the specifications and there is no consequence in the use of the products.
  • Causa
    B. braun laboratories has identified that the certificates of the above serial numbers of the enteromat compact infusion pump equipment have been issued with incorrect information in the fields intended for calibration results. this is a human error, unique and exclusively related to the stage of issuing the certificates.
  • Acción
    The company that holds the registration in Brazil requests the return of the incorrect Calibration Certificates that are in the possession of the customers, which will be replaced by the duly corrected revision.

Device

Enteromat Compact Infusion Pump, Registration 80136990431 - Number of series A4491, A4493, A4494,...

Manufacturer

Laboratórios B. Braun S.A.