Warn about Potentially Fatal Complications. Fresenius has been under scrutiny for failing to warn about complications associated with their GranuFlo and NaturaLyte dialysis products. Dialysis is a procedure that helps filter toxins from the blood in patients who have had kidney failure. The alkaline substance bicarbonate is used in dialysis to help neutralize the acid that builds up in the blood.
Fresenius’ GranuFlo and NaturaLyte contain acetate, which gets converted into bicarbonate once it is metabolized by the liver. These products, however, contain higher levels of acetate and therefore contribute higher levels of bicarbonate than competing products.
Unfortunately for consumers, evidence shows that Fresenius knew about the risks of high bicarbonate levels long before the recall in 2012. Company officials have been aware of the metal alkalosis risk since GranuFlo and Naturalyte were approved in 2003.
Even though Fresenius Medical Care knew that excess levels of bicarbonate were associated with serious, potentially fatal consequences the company did not warn clinics that used the products or the U.S. Food and Drug Administration (FDA).
941 patients had suffered cardiac arrest inside Fresenius clinics in 2010
An internal company memo, dated November 4, 2011, warned that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. The memo attributed part of the problem to dosing errors, where doctors did not account for the extra alkalinity from GranuFlo and NaturaLyte.
Fresenius did not warn outside consumers or the public about these risks until prompted by the U.S. Food and Drug Administration (FDA) on March 27, 2012. Only afterwards did Fresenius issue an Urgent Product Notification to non-Fresenius Clinics.
In June 2012, the FDA issued a Class I recall for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate.
The agency warned about higher bicarbonate levels with these products, stating that “This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”