HOMECHOICE FOR PERITONEAL DIALYSIS. 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.

According to the company, corrective action was initiated due to recent complaints of excess drainage involving patients with hepatic and renal failure using HomeChoice. The patient had ascites (abnormal fluid accumulation in the peritoneal cavity) and according to the report, there was an initial drainage of 6 liters. For the incident, the risk of using HomeChoice (version 10.4) was studied in patients with ascites, as they may present with increased volume of fluid in their peritoneal cavity. The HomeChoice is designed to empty the peritoneal cavity during Initial Drainage, the software with previous versions allowed the operator to stop the active Initial drainage and to avoid it. Software with a current version (version 10.4) allows the operator to stop active initial drainage, but does not allow the operator to avoid it, as it has removed the option of avoiding "active initial drainage" to decrease the unwanted increase in Intraperitoneal volume ( IIPV). Physicians who use the HomeChoice machine to treat patients diagnosed with End Stage Renal Disease who have Ascites should be aware that during treatment the device will attempt to drain the patient for emptying at the start of therapy (Initial Drainage). Patients diagnosed with ascites comorbidity who are drained for emptying may be at high risk of hypotension and compromised hemodynamic status. See detailed information at: http://portal.anvisa.gov.br/wps/wcm/connect/a6d3c40041bb18f49334d79d63c1a945/Carta_ao_cliente.pdf?MOD=AJPERES