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Cardiac Arrest and Death in Patients Who Were Administered GranuFlo

passenger-traffic-122999_640.jpgHemodialysis is like taking off in a commercial airliner-over and over again, twice a week, every week, for years on end. Because when you’re on dialysis you have to have blind faith in the process. The patient is the passenger, and someone else is flying the plane.

Fresenius Medical Care, a powerful corporation based in Germany that specializes in kidney dialysis supplies, is the maker of dialysis additives GranuFlo and NaturaLyte, and the largest operator of hemodialysis clinics in the U.S. Last year, the FDA issued an alert and recall related to GranuFlo, a potentially dangerous acid concentrate product.

The product has been administered to some kidney patients in connection with hemodialysis, a procedure that cleans or filters toxins from the blood when a kidney patient’s kidney is too diseased or impaired to do the same task.

The goals of hemodialysis are to: remove waste products from the blood just as a healthy kidney would and to make sure the patient’s blood is not too acidic or not acidic enough. Also, hemodialysis patients’ blood must have the right amount of potassium for the heart to beat correctly. Patients who have kidney failure or disease are more likely than people without these conditions to have excessive acid buildup in the blood and potassium imbalance. Having the right amount of acidity and potassium in the blood is critical. Too much is fatal, and too little is fatal. The acidity of blood and the blood level of potassium must be kept in a normal range, like temperature and heart rate and blood pressure. Otherwise death will occur.

Hemodialysis patients undergo the procedure three times a week under the care of nursing and technical personnel. The procedure starts by connecting a patient to a dialyzer. As blood from the patient’s artery passes through a dialyzer, the blood goes through tiny tubes. Flowing the opposite direction from the blood, separate but interacting with it, is a liquid that contains a mixture of chemicals critical to cleansing the blood and keeping blood in balance so that blood is not too acidic or not acidic enough.

GranuFlo is a dry product that must be mixed with liquid in exactly the right proportions. GranuFlo is a dialysis product that was often used before a 2012 FDA recall. GranuFlo has a chemical in it called acetate. Not all patients need the same amount of acetate. Acetate in the blood is converted to bicarbonate in the blood. Some patients who received GranuFlo had higher than acceptable levels of bicarbonate. Too much bicarbonate circulating in the blood causes Potassium blood levels to drop. Low blood levels of Potassium lead to electrical shutdown, and electrical shutdown means the heart stops beating, resulting in cardiac arrest and death. Some patients who received GranuFlo before the FDA recall notice were at increased risk for cardiac arrest.

Not all patients show symptoms of electrolyte imbalance and impending cardiac arrest. If you or a loved one has been injured by GranuFlo or another pharmaceutical agent, contact the products liability attorneys at Briggs & Wholey, LLC by phone or via our online form for a free consultation.

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