Naturalyte and Granuflo are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
The U.S. Food and Drug Administration (FDA) announced a Class I recall on the dialysis product GranuFlo and NaturaLyte due to serious side effects.
Fresenius is the manufacturer of a wide range of dialysis products. On March 29, 2012, the company sent an “Urgent Product Notification” to their clinics and customers of the increased risk of bicarbonate overdose when dialysates are mixed incorrectly as a result of human error.
Incorrectly mixed dialysate results in increased bicarbonate levels which can place patients at a high risk of metabolic alkalosis. This is a significant risk factor associated with cardiac arrhythmia, hypercapnia, hypokalemia, hypoxemia, and low blood pressure which, if not appropriately treated, may cause cardiopulmonary arrest. This product has been known to cause serious adverse health consequences, including death.
Here are some serious side effects associated with Granuflo and NaturaLyte:
- Cardiopulmonary arrest
- Heart attack or myocardial infarction
- Heart Problems
- Low blood pressure
- Metabolic alkalosis
- Stroke
- Death
If you or someone you love has been injured or killed as a result of the dialysis products Granuflo and NaturaLyte, you may have a claim. We urge you to call us today at 888-We-Mean-It (888-936-3264) or you can email us at [email protected]. Any initial consultation with our firm is free.
