After almost 1000 dialysis patients developed cardiac arrest or irregular heartbeats at Fresenius Dialysis Clinics, the U.S. Food and Drug Administration (FDA) issued a Class I recall for GranuFlo and NaturaLyte dialysis concentrates. The FDA issued a recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate.
The dialysate is a solution prescribed by nephrologists or kidney doctors for use in the treatment of acute or chronic renal failure and end stage renal disease (ESRD) during dialysis. The solution is used to help remove wastes from the body that the kidneys can no longer excrete. The dialysate acid solution can contain acetic acid, citrate or acetate which are substances that can be converted in the body to bicarbonate. If the body has too much bicarbonate it can cause the dialysis patient to develop metabolic alkalosis or too much buffer in the blood. If a patient on hemodialysis or peritoneal dialysis develops alkalosis it could lead to low blood pressure (hypotension), hypokalemia (low potassium), hypoxemia (low oxygen level), hypercapnia (high carbon dioxide level) and cardiac arrhythmia, which, if not diagnosed and treated, could result in cardiopulmonary arrest, hypoxic ischemic encephalopathy (brain damage), organ failure and sudden death.
In November 2011, Fresenius internally informed physicians and nephrologists at its own dialysis clinics of the high rate of cardiac arrests in 2010, but failed to warn the general public until an anonymous copy of the letter was sent to the FDA. Once the FDA became aware of the situation and investigated, a recall notice was released and Fresenius issued an Urgent Product Notification to all of its customers.
If you or a loved one suffered cardiac arrest, brain damage, organ failure or other serious bodily injury while undergoing a dialysis treatment you may be eligible for compensation. Please feel free to contact one of our experienced pharmaceutical litigation lawyers, doctors, or nurses for a strictly confidential and free consultation.
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