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Review of Dialysate Warnings

Hemodialysis, a type of kidney dialysis, is the process of cleansing the blood and removing excess fluid through an artificial kidney (dialyzer) using a hemodialysis machine and a dialysis solution called dialysate. Dialysate is a prescription formula that contains specific amounts of acid concentrate, bicarbonate concentrate, and ultrapure water.  

Recently, Fresenius Medical Care North America (FMC) recalled two of their acid concentrates—GranuFlo Acid Concentrate (a powder) and NaturaLyte Liquid Acid Concentrate. The recall was classified as Class I— the most serious type that involves situations where there is a reasonable probability that the use of the product will cause serious health consequences or death. The products were recalled due to misleading product labeling that can lead to potentially fatal dosage errors.

The recall of GranuFlo and NaturaLyte prompted the Federal Drug Administration (FDA) to warn medical professionals about all acid concentrates used in the dialysate solution—not just GranuFlo and NaturaLyte. The FDA stated that acid levels in acid concentrates vary by manufacturer and health care providers should review the label on the specific brand of dialysate acid concentrate they prescribe to determine how it contributes to overall bicarbonate levels. Too much acid in the dialysate solution can lead to elevated bicarbonate levels when metabolized.

Elevated bicarbonate levels contribute to metabolic alkalosis, a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia, and death.  Hemodialysis patients should discuss the situation with their doctor to ensure the level of acid in their dialysate solution is appropriate and does not result in elevated bicarbonate levels.

If you or a loved one had a hemodialysis treatment using GranuFlo or NaturaLyte between January1, 2008, and June 30, 2012, and suffered a heart attack or some other serious cardiac injury during or shortly afterwards, you may be eligible for compensation. To find out more, contact a GranuFlo kidney dialysis attorney at Schmidt Kramer. The toll free number is (717) 888-8888 and the case review is free.