In June of 2012, the US Food and Drug Administration (FDA) issued a Class I recall of GranuFlo Dry Acid Concentrate and Naturalyte Liquid, dialysis products used in the treatment of acute and chronic renal (kidney) failure during hemodialysis. Class I recalls are used for dangerous or defective products and are considered to be the agency’s most serious medical device recall.
GranuFlo, a dialysis product manufactured by Fresenius, is used to clean the blood of patients undergoing hemodialysis for treatment of renal (kidney) failure. It is estimated that GranuFlo is used by more than a third of the 400,000 hemodialysis patients located in over 5,700 dialysis centers across the United States.Why the Recall Was Issued
The FDA began an investigation into Fresenius products GranuFlo and Naturalyte after a memo written by Fresenius was leaked. This memo confirmed the significant risk of cardiopulmonary arrest and death among patients using GranuFlo.
The memo leaked to the FDA was intended to be seen by only physicians and clinics that were associated with Fresenius, leaving many dialysis clinics in the dark and potentially endangering thousands of lives.
The mixing and administrating instructions on the packaging of GranuFlo were incomplete. As a result, bicarbonate levels could not be measured, creating a higher risk for bicarbonate overdosing. The memo referenced 941 patients treated at FMC clinics who suffered cardiac arrest during or shortly after taking GranuFlo.
GranuFlo is a widely used dialysis product due to its powdered formula of acetic acid (sodium diacetate). The powdered formula is desired by many physicians because they can mix their own dialysate solution, and Hospitals prefer the powdered formula because it reduces shipping costs inflated by large 55-gallon drums.Serious Injuries and Side Effects Associated with GranuFlo
- Cardiopulmonary arrest
- Heart issues
- Metabolic alkalosis low blood pressure
- Cardiac arrhythmia
- Sudden heart attack
Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.
Before writing the bicarbonate component of the dialysate prescription or using the dialysate concentrates:
- Review the dialysate acid concentrate labeling for the specific concentrate that you prescribe or use to determine the components that can contribute to the patients bicarbonate level. The levels of acetate, citrate, and/or acetic acid vary by product and manufacturer.
- Be sure to understand how your specific hemodialysis device proportions or mixes the acid and base concentrates.
- Be aware that some dialysate acid concentrates contain acetate, citrate, and acetic acid level combinations up to 8mEq/L, and some products may contain both acetate and acetic acid.
If you or a loved one has experienced a cardiac event, stroke, or death after dialysis, please fill out a contact form or call the Branch Law Firm. We have experienced lawyers and a knowledgeable support staff who can assist you.