Events

Alerta De Seguridad para PORTABLE SYSTEM OF REVERSE OSMOSIS. Anvisa Record: 80145240358. Product Codes: 5M5509, 5M5509R, 5M1313, 5M1313R, 5M1293 and FM4644.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Healthcare Corporation; BAXTER HOSPITALAR LTDA..

¿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
    948
  • Fecha
    2008-11-03
  • 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
    FILMTEC, a supplier of the FIL FILMTEC filter membranes for BAXTER, made changes to the instructions for use of the membranes. The new information contained in the instructions for use of these membranes is: (1) Saturated water obtained after the first hour of use should be discarded in the drain; and (2) Protective gloves and sleeves to avoid prolonged contact with skin and clothing. Users of the product are encouraged to read and perform these new operating instructions. To access the Letter to Clients disclosed by the company, access: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/948_carta.pdf
  • Causa
    Change of instructions for use of reverse osmosis membranes used in baxter's portable reverse osmosis system.
  • Acción
    FILMTEC, a supplier of the FIL FILMTEC filter membranes for BAXTER, made changes to the instructions for use of the membranes. The new information contained in the instructions for use of these membranes is: (1) Saturated water obtained after the first hour of use should be discarded in the drain; and (2) Protective gloves and sleeves to avoid prolonged contact with skin and clothing. Users of the product are encouraged to read and perform these new operating instructions.

Device

PORTABLE SYSTEM OF REVERSE OSMOSIS. Anvisa Record: 80145240358. Product Codes: 5M5509, 5M5509R, 5...

Manufacturer

Baxter Healthcare Corporation; BAXTER HOSPITALAR LTDA.