GranuFlo and NaturaLyte Dialysis Solutions

Lawyers at Wilentz, Goldman & Spitzer, PA., are offering complimentary consultations to individuals and the families of individuals who suffered cardiac arrest or sudden cardiac death while undergoing dialysis treatment. Dialysis patients who suffered cardiac arrest at a dialysis clinic using a dialysis product distributed by Fresenius may be entitled to compensation.

On June 27, 2012, the Food & Drug Administration (“FDA”) issued a Class I Recall notice for Fresenius Medical Care North America NaturaLyte Liquid Concentrate and NaturaLyte GranuFlo (powder) Acid Concentrate (see U.S. FDA Medical Device Recall). The recall was due to the risk of high serum bicarbonate levels in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, a significant risk factor associated cardiac arrest sudden cardiac death.

The FDA previously worked with Fresenius Medical Care on an Urgent Product Notification that was released to Fresenius customers on March 29, 2012. The notice cautioned clinicians to be aware of the concentration of acetate or sodium diacetate contained in the products. Fresenius product formulations have total buffer equal to “prescribed bicarbonate plus 8.” Fresenius previously disclosed this information to its own facilities in November, 2011, but failed to inform all of its customers (see Fresenius Internal Memo).

There have been instances whereby physicians’ bicarbonate prescriptions were kept the same when shifting to Fresenius products, thus exposing patients to a higher total buffer load than intended, and the potential for deadly adverse reactions connected to excessive dosing from the Fresenius products.

If you or someone you know has suffered a cardiac arrest while undergoing dialysis, please contact the attorneys at Wilentz today.


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