Fresenius Medical Care manufactured GranuFlo and NaturaLyte dialysate to be used for dialysis in patients suffering from chronic kidney disease and renal failure. The Food and Drug Administration (FDA) approved GranuFlo in 2003 through a process called 510(k) of the Food, Drug, and Cosmetic Act. In this process, a premarketing submission is made which says that the device is substantially equivalent to a drug already placed in the market.
When patients are given incorrect doses, the side effects of GranuFlo and NaturaLyte increase significantly. Reports indicate that hundreds of patients suffered GranuFlo side effects caused by excessive bicarbonate levels, which was underestimated by many medical professionals. One of the major side effects is metabolic alkalosis.
Food Machinery Corporation (FMC) Corporation, an American chemical manufacturing company, released an urgent internal memo to more than 1,800 FMC clinics in 2011. The report suggested that 941 patients in 2010 suffered cardiac arrest and other GranuFlo side effects after receiving dialysis treatment in an FMC clinic. It also emphasized on the importance of proper dosing to patients. However, the company is being accused of misconduct as they notified its own clinics but failed to notify the FDA or the thousands of other facilities that administered GranuFlo and NaturaLyte.