The Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo and NaturaLyte acid concentrates after a leaked internal memo from Fresenius Medical Care revealed a link between metabolic alkalosis and the dialysis acid concentrates GranuFlo and NaturaLyte.
Metabolic alkalosis occurs when high bicarbonate levels in the blood stream create a pH imbalance. Symptoms of metabolic alkalosis include low blood pressure, vomiting, muscle twitching and heart rhythm problems. In severe cases, metabolic alkalosis can result in heart attack, stroke or sudden death.
In the memo, Fresenius Medical Care reported that GranuFlo and NaturaLyte can heighten the bicarbonate blood levels of patients with elevated pre-dialysis bicarbonate levels to dangerous heights. According to Fresenius studies, patients with elevated bicarbonate levels were six times more likely to suffer a heart attack or sudden cardiac death from GranuFlo or NaturaLyte than patients being treated with other dialysis concentrates.
If you or a loved one experienced symptoms of metabolic alkalosis after receiving hemodialysis treatment with GranuFlo or NaturaLyte, contact the lawyers at Hissey Kientz, LLP for a free case evaluation. You can reach us by calling toll-free at 1-866-275-4454, or by filling out our free contact form on the right of this page.