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GranuFlo Linked to Deaths in Dialysis Patients

In June 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 that may cause serious health problems or even death.

Manufactured by German manufacturer, Fresenius (FMC), GranuFlo is a dialysis product that is used to clean the blood of patients undergoing hemodialysis for treatment of renal (kidney) failure. GranuFlo is used by more than a third of the estimated 400,000 hemodialysis patients at over 5700 dialysis centers in the United States.

Why Was the Recall Issued?

The FDA began an investigation into Fresenius products GranuFlo and Naturalyte, a sister drug, after an internal memo dated November 4, 2011, was leaked.  This memo, sent only to the physicians and clinics that were associated with Fresenius, confirmed the significant risk of cardiopulmonary arrest and death among patients undergoing dialysis treatment. This was due to an incorrect dialysis concentration. According to this memo, 941 patients treated at FMC clinics had suffered cardiac arrest during or shortly after treatment with GranuFlo.

Unfortunately, Fresenius did not share this potentially life-saving information with other physicians and clinics not associated with FMC that may still be using their products or the FDA. It was not until four months later in March 2012 that this memo was leaked to the FDA.

Why is GranuFlo so Dangerous?

GranuFlo is the only dialysis solution product containing the powdered form of acetic acid (sodium diacetate). This powered form is desired by the clinics as it allows them to mix their own dialysate solution as well as avoiding the higher shipping costs of the 55 gallon drums of pre-mixed solution.

However, the mixing and administrating instructions on the packaging of GranuFlo were incomplete. As a result, errors were made which put dialysis patients at a higher risk of bicarbonate overdosing.

Serious Injuries and Side Effects

Bicarbonate overdosing due to GranuFlo can cause serious health problems for dialysis patients for up to two years after use. If you have had any of these side effects after dialysis treatment with GranuFlo, you may have a legal claim against the manufacturer.

  • Cardiopulmonary arrest
  • Heart issues
  • Metabolic alkalosis
  • Low blood pressure
  • Cardiac arrhythmia
  • Sudden heart attack
  • Stroke
  • Death

GranuFlo has been used by over a third of estimated 400,000 hemodialysis patients at over 5700 dialysis centers in the U.S.  Revenue from sales of GranuFlo per year in the U.S. is estimated to be at least $80 million. 

Important News for Physicians or Clinics That Use GranuFlo

From the FDA Alert 

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 patient’s 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 (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 have used GranuFlo and have patients that have suffered the conditions listed above or have died, please join with us as we work to hold Fresenius responsible.

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