There are approximately 400,000 patients in the United States who visit a dialysis center three times a week. Patients suffering from chronic kidney disease or kidney failure require artificial means to filter blood, which is done through dialysis. The process removes waste and excess water from the blood stream via a dialysis machine, and is then circulated back into the patient’s body. Because patients’ lives depend on this treatment it is critical for the system and products used in the procedure to be safe.
Risks Associated With Dialysis
Although artificial filtration is nowhere near as effective as the kidneys, this process prolongs life for many people, hopefully until a kidney transplant is possible. But as it is an artificial process, complications can arise either from hemodialysis or the underlying kidney disease. Some of the most common complications linked to hemodialysis patients include:
- Fluid overload
- Inflammation of membrane
- Bone diseases
- High potassium levels
Dialysate and Bicarbonate
As the blood passes through the dialysis machine, a chemical solution called dialysate is circulated in the opposite direction across a permeable membrane. Through the permeable membrane, waste is filtered from the blood and a prescribed dose of bicarbonate is absorbed into the blood before entering the body. Bicarbonate is an important component that prevents blockages in the blood stream and maintains a balanced pH level. However, too much bicarbonate in kidney patients can be fatally dangerous, especially because without functioning kidneys, the excess cannot be filter out without another dialysis session.
Sodium Acetate in Acid Concentrates
Acid concentrates can come in either dry or liquid form, which is then diluted by health technicians according to individual prescriptions and used as dialysate. Fresenius Medical Care (FMC) manufactures two of the most widely used acid concentrate solutions, GranuFlo and NaturaLyte, both of which have been recalled in early 2012. Unlike many other brands of acid concentrates, GranuFlo and NaturaLyte include both acetic acid and sodium acetate. Findings from an internal study conducted in 2010 concluded that the sodium acetate has a tendency to convert into bicarbonate once it passes through the body, putting patients at risk of higher-than-prescribed levels of bicarbonate, and increasing the risks of cardiac arrest.
GranuFlo and Cardiac Arrest Risks
Whether in dry or liquid form, sodium acetate can lead to unintentionally high levels of bicarbonate that can increase the risk of cardiac arrest by as much as 6.3 times. In 2010, while the study was being conducted, over 941 patients died from cardiac arrests that may have been related to the unexpected sodium acetate conversion. In light of the FDA recall of the FMC acid concentrates and hundreds of adverse event reports, patients or families of patients who have suffered cardiac arrest while undergoing dialysis treatment at a FMC facility are strongly urged to consult a professional product liability lawyer. A knowledgeable attorney may be capable of helping you recover compensation for additional medical bills and other damages related to any adverse event.