Events

Alerta De Seguridad para HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER. Model: HOMECHOICE. ANVISA Registration No. 10068390123.

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
    1392
  • Fecha
    2014-06-05
  • 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
    Baxter Hospitalar Ltda has begun sending alert messages to users of the HOMECHOICE PERITONEAL DIALYSIS equipment, warning of the risk of excessive fluid retention in the peritoneal cavity in dialysis procedures performed on newborns, infants, young children and any patient with significant heart disease or pneumonia. The alert details the observed symptoms and the necessary measures in case of occurrence of the problem. SEE COMPLETE INFORMATION IN WARNING LETTERS DISCLOSED BY THE COMPANY, AVAILABLE AT http://portal.anvisa.gov.br/wps/connect/c6b5e100444534a58d98ed7ad3496059/FCA+2014+017+Carta+ao+Paciente.pdf?MOD=AJPERES (LETTER TO THE PATIENT) E http://portal.anvisa.gov.br/wps/wcm/connect/72fdb600444534198d8fed7ad3496059/FCA+2014+017+Carta+a+Dialise.htm.pdf?MOD=AJPERES (LETTER TO THE CENTER OF DIALYSIS).
  • Causa
    Risk of unintended increase in intraperitoneal volume (iipv) during dialysis therapy in particularly vulnerable patients (newborns, infants, young children, patients with heart disease or significant pneumonia).
  • Acción
    The company is issuing a safety alert for users of the product (letter), warning of the risks, symptoms and care to be taken to minimize the problem.

Device

HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER. Model: HOMECHOICE. ANVISA Registration No. 10068390123.

Manufacturer

BAXTER HOSPITALAR LTDA.