Alerta De Seguridad para Extracorporeal circulation tube set. CDBA Code 105 - Lots 03023003, 030310001 and 030327001.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por EDWARDS LIFESCIENCES MACCHI 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
    715
  • Fecha
    2003-04-22
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    As a preventive measure, perfusionists before surgical procedures calibrate arterial lines using partial or total occlusion techniques, where the deviation will be detected and provided for replacement if necessary. Make sure you have received an explanatory note from the company and have exchanged the committed lot. For more information, contact your local representative or directly with the company at 11-55675270.
  • Causa
    The company informs that it has observed that the batch of hospital pvc tubes (code cdba 105 - lots 03023003, 030310001 and 030327001) used in the arterial line (machine line) is oscillating hardness, and in some cases tubes with hardness above the calibration of the rollers of the extracorporeal circulation machines.
  • Acción
    The company manufactured separate arterial lines and sent the customers who received the committed lots, along with explanatory chart until new batches of trays are available.

Manufacturer