What is GranuFlo/NaturaLyte?

dialysis

Information Provided by a Mississippi Medical Malpractice Lawyer

GranuFlo/NaturaLyte is a medication, manufactured by Fresenius Medical Care and used in the treatment of renal failure during hemodialysis, to assist in cleaning a patient's blood. This medication has been recalled by the FDA, after a Fresenius memo was leaked to the FDA, in which the company failed to warn its customers that their products have been linked to an increased risk of cardiac arrest events.

Dialysis Risk Associated with GranuFlo and Naturalyte

The U.S. Food & Drug Administration recently declared a Class I recall of Fresenius Medical Care's GranuFlo and NaturaLyte dialysis products. After an the leaking of an internal Fresenius memo to the FDA, the company warned consumers that the products have been linked to a contributing factor in cardiac arrest.

The FDA website states, "FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death."

Fresenius Medical Care, treats more than a third of the Americans receiving dialysis. It also is the leading supplier of dialysis machines and disposable products, which are used by many clinics in addition to its own.

Late last year, in 2012, Fresenius’s medical office sent ”Dear Doctor” warning to doctors practicing in the company’s dialysis centers, warning them that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest. Fresenius, a German Company, did not immediately warn other centers that use GranuFlo. It warned them in March, 2013, after the F.D.A. received.

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