Dialysis Systems by Baxter called HomeChoice and HomeChoice PRO are under a medical device recall following reports from physicians that people have experienced serious injury and one known death because of a defect in the product. The specific defect is unknown at this time. What is known is that the Automated PD system which is programmed to repeatedly deliver and remove dialysis solution may produce increased Intraperitoneal Volume (IIPV). Intraperitoneal Volume (IIPV) is described as overfilling of the abdominal cavity.
Intraperitoneal Volume (IIPV) is known to cause serious breathing difficulty, hernias of the abdomen or diaphragm, pulmonary dysfunction, hypertension, hydrothorax, pericardial effusion and peritonitis. Dialysis patients that are children or are seriously ill are at an increased risk of injury from the affected models of Baxter’s Dialysis System.
Some physicians may still be using Baxter’s HomeChoice and HomeChoice PRO. If they are still using Baxter’s Dialysis Systems, they are being advised by the FDA to inform dialysis patients about the risk associated with HomeChoice and HomeChoice PRO.