The Food & Drug Administration issued a Class 1 recall for several models of home kidney dialysis machines made by Baxter Healthcare Corp. (NYSE:BAX).
Regulators say a problem with the dialysis machine is causing “increased intraperitoneal volume” or an overfill of the abdominal cavity with liquid, leading to injuries and at least one reported death.
Deerfield, Ill.-based Baxter says it has received reports of IIPV for the past two years. Although it is not removing the products from the market, the company is warning patients to keep an eye out for signs of IIPV, particularly in children, non-verbal patients and the critically ill.
The company says symptoms to watch out for include “difficulty breathing; vomiting or spitting up; a child complaining of a ‘funny feeling’ in the abdomen; a child crying during therapy without other apparent reasons; difficulties feeding; feeling full, bloated, or overfilled after treatment; abdominal pain or discomfort; expanded or tense abdomen; localized swelling around the genital area (labia, scrotum) or groin region, belly button, the tunnel tract of the peritoneal dialysis catheter or the PD catheter exit site; leakage of fluid from the PD catheter exit site; and unexpected increase in blood pressure.”
Affected models include HomeChoice systems model numbers: 5C4471, 5C4471R, 5C8310, 5C8310R, 5C4474, 5C4474R, R5C8320, R5C8320R, T5C4441, T5C4441R, T5C8300, T5C8300R, 5C4474D and 5C4474DR.
Baxter said it is working to correct the problem and has “developed and is validating a software modification to address this issue and plans to submit a 510(k) to the FDA mid-year,” according to a press release.
The company’s renal division, which includes in-center and home dialysis products, accounted for about $2.2 billion of the $12.5 billion in total sales Baxter reported in 2009.