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

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.

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).