Events

Alerta De Seguridad para Ventricular Catheter (AESCULAP ​​HYDROCEPHAL SYSTEM, Registration no. 80136990434 - lot: 4505252662 and PROGAV - GRAVITACIONAL VALVE FOR AESCULAP ​​HYDROCEPHAL, Registration 80136990624 - Serial numbers / codes Annex)

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
    1386
  • Fecha
    2014-05-09
  • 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 problem can occur when the surgeon moves the baffle, not being possible to do it without damaging the catheter. However, this problem is detectable by the surgeon during implantation. Thus, the risk to the patient is low and detectable. In addition, in most cases of implantation the ventricular-deflector catheter combinations are implanted without deflector movement.////// UPDATE - 07/18/2014 - The company closed the field action and the collected units were returned to the manufacturer.
  • Causa
    The company that holds the registry informs about the possibility of rupture of the ventricular catheter within the baffle. this problem may occur during implantation of the baffle, with the movement of the catheter, since the baffle attaches very strongly to the ventricular catheter. the problem is caused by deviations in the tolerance limit of the external diameter of the ventricular catheter.
  • Acción
    The company that holds the registration in Brazil requests the interruption of the distribution of said products / lots, which are still in the customer's stock, segregation thereof, information to Laboratorios B. Braun SA of the quantities of existing units of each product code and number of lot. If the aforementioned products have already been implanted, and the surgeon has noticed that signs that the Shunt is not working properly, we recommend that an investigation be done on these patients.

Device

Ventricular Catheter (AESCULAP ​​HYDROCEPHAL SYSTEM, Registration no. 80136990434 - lot: 45052526...

Manufacturer

Laboratórios B. Braun S.A.