Events

Alerta De Seguridad para DIACAP ULTRA - DIÁLISE FLUID FILTER - Registration 8013990617 - Lots / Series affected - See annex. http://en.wikipedia.org/w/index.php/

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
    1241
  • Fecha
    2013-04-11
  • 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
    The manufacturer makes clear that only the Diacap Ultra product more than 10 months after the date of manufacture are affected by this nonconformity. There are no records in the NOTIVISA system to date. UPDATE 10/10/2013 - The company informed ANVISA that the field action was completed, and the products collected were sent to destruction.
  • Causa
    Over time, the residual moisture of the membrane of the diacap ultra products may decrease, causing a reduction in membrane permeability (ultrafiltration coefficient).
  • Acción
    The manufacturer recommends discontinuing the use of said lots, segregating them, informing B. Braun SA Laboratories of the quantities of existing units of each batch number. See attached Letter to the Client. http://en.wikipedia.org/w/eng/index.php

Device

DIACAP ULTRA - DIÁLISE FLUID FILTER - Registration 8013990617 - Lots / Series affected - See anne...

Manufacturer

Laboratórios B. Braun S.A.