Events

Alerta De Seguridad para Locking Titanium Adapter for Peritoneal Dialysis Catheter (Anvisa Registry # 10068390171); 6 "Transfer Kit with Long Stay Twist-Clamp (Anvisa Registration No. 10068390005); Prep Kit for CAPD-SDD (Anvisa Record 10068390336).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por 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
    1503
  • Fecha
    2015-02-04
  • 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 company will add a phrase in the instructions for use of the disconnection systems, warning that the product should not be used in patients with a known history of allergic reactions to iodine. Check full information in the alert message published by the company, available at: http://portal.anvisa.gov.br/wps/wcm/connect/99fa2e00472fc243aafebbbb1e455ac3/Carta+ao+Cliente.pdf?MOD=AJPERES
  • Causa
    Warning about the need to observe the situation of iodine allergy in the patient undergoing peritoneal dialysis, using any of the products mentioned in this alert.
  • Acción
    The products in question should not be used during therapy (peritoneal dialysis) in patients with a history of iodine allergy. The company is sending customers a safety alert with an update of the instructions for use.

Device

Locking Titanium Adapter for Peritoneal Dialysis Catheter (Anvisa Registry # 10068390171); 6 "Tra...

Manufacturer

BAXTER HOSPITALAR LTDA.