Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BAXTER HOSPITALAR LTDA..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1392
  • Date
    2014-06-05
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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).
  • Reason
    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).
  • Action
    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.