The Dangers of GranuFlo & NaturaLyte

GranuFlo Acid Concentrate (GranuFlo) is used by doctors who treat patients who are suffering from kidney failure and need dialysis. It is a powder that must be mixed with purified water and sodium bicarbonate, and it is then delivered through a hemodialysis machine to clean the patient’s blood. NaturaLyte Liquid Acid Concentrate (NaturaLyte) is the name of the liquid form of this product.

Almost 50% of the people who need dialysis have been treated with GranuFlo or NaturaLyte, and an alarming number of these people have experienced cardiovascular events, heart attacks, or even death due to the product’s high bicarbonate levels. Excess bicarbonate from GranuFlo or NaturaLyte can cause:

• Cardiac arrhythmia
• Low blood oxygen
• Low blood potassium
• Cardiac arrest
• Low blood pressure
• Increased blood carbon dioxide

The product is manufactured by Fresenius Medical Care North America, and records show that more than 900 patients suffered heart attacks in Fresenius clinics in 2010. In November 2011, the company issued a warning to doctors who were associated with the Fresenius clinics that the bicarbonate levels in patients could be unsafe and advised the doctors to adjust the dialysis settings for the high level of bicarbonate. The company did not inform other doctors. An anonymous whistleblower inside the company knew of the risk and reported it to the U.S. Federal Drug Administration (FDA).

As more and more people became injured by this product, many lawsuits were filed against the company. They alleged that Fresenius knew about the dangers and intentionally, negligently and/or recklessly misrepresented, hid or suppressed the risks. Some of the injuries and damages reported were:

• Mental and physical pain
• High cost of extra medical care
• Loss of wages and future wages
• Death

The FDA issued a warning that the incorrect use of GranuFlo or NaturaLyte could cause fatal side effects, and later announced a Class 1 recall on this product. A Class 1 recall is the most serious type of recall and is reserved for situations where use of a product has a high probability of resulting in serious injury or death.