GranuFlo FAQs

NaturaLyte Liquid Acid Concentrate and GranuFlo Dry Acid Concentrate are used during hemodialysis in the treatment of acute and chronic renal failure. They are supplements provided to replace amino acids that are removed from the body during dialysis. They were manufactured and distributed from January 2008 through June 2012.

NaturaLyte and GranuFlo are made by Fresenius Medical Care North America of Waltham, Massachusetts. Fresenius is the world’s largest manufacturer of kidney dialysis machines, equipment and products. It also operates many dialysis clinics across the United States.

GranuFlo and NaturaLyte are concentrations of acetate or sodium diacetate (acetic acid plus acetate). They are formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates. Infusions of GranuFlo / NaturaLyte are meant to raise the serum bicarbonate level in patients undergoing hemodialysis to a proper pH balance. But if GranuFlo / NaturaLyte is administered in improper dosages, it can lead to a serum bicarbonate level that is too high.

A high serum bicarbonate level caused by an improper dose of GranuFlo / NaturaLyte during hemodialysis may contribute to metabolic alkalosis. This is a significant risk factor associated with a variety of blood irregularities, including low blood pressure, hypokalemia, hypoxemia and hypercapnia, which can cause cardiac arrhythmia. Cardiac arrhythmia, an irregular heartbeat, if not appropriately treated, may lead to heart failure or heart attack (cardiopulmonary arrest).

Yes. The FDA issued a Class I recall for NaturaLyte and GranuFlo on March 29, 2012. Class I recalls are the most serious type of recall. They involve situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death. The FDA also issued a general safety communication on May 25, 2012, related to inappropriate prescription and resultant alkali dosing errors in dialysate concentrates used in hemodialysis.

At the National Kidney Foundation’s 2011 Spring Clinical Meetings, panelists presented the results from retrospective evaluations of 50 hemodialysis patients hospitalized in October 2010 who had received GranuFlo and/or NaturaLyte. The report said 54 percent of the patients had a serum bicarbonate level that was above the level indicative of metabolic alkalosis.

Fresenius Medical Care North America (FMC), the manufacturer of GranuFlo and NaturaLyte, alerted physicians and medical directors of the firm’s dialysis clinics in a November

2011 internal memo that GranuFlo “appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest,” according to the New York Times.

The same day the FDA issued its recall notice, FMC sent an “Urgent Product Notification” to its clinics and customers. The notice said that analyses of the company’s data about hemodialysis patients using NaturaLyte and GranuFlo “confirms that alkalosis is a significant risk factor associated with cardiopulmonary arrest in the dialysis unit.”

There are no documented deaths attributed to the administration of NaturaLyte or GranuFlo during dialysis. However, an internal Fresenius Medical Care North America (FMC) memo uncovered and reported by RenalWEB, a website devoted to dialysis, says 941 patients suffered cardiac arrest inside Fresenius clinics in 2010. Sudden cardiac arrest is the leading cause of death for dialysis patients, according to RenalWEB.

If you know that you or a loved one was treated with NaturaLyte / GranuFlo during dialysis and suffered a serious adverse reaction, you should contact an experienced personal injury lawyer who has successfully pursued cases involving dangerous pharmaceuticals and faulty medical devices. Next, you should contact your doctor(s) and request copies of your medical records.

A GranuFlo / NaturaLyte injury lawyer with The Driscoll Firm, LLC, will provide you with a free initial consultation about your case and with no further obligation on your part. If The Driscoll Firm, LLC, believes it can successfully pursue a legal claim on your behalf, and you choose to do so, there will be no charge to you until we obtain a settlement or court-ordered award. Our fee will be a nominal percentage of the final settlement or award.

Contact The Driscoll Firm, LLC, at our toll-free phone number or through our online form to speak with a GranuFlo / NaturaLyte injury lawyer.

You may also consult these sources, which were useful in preparing answers to the FAQs above:

• Medical Device Recalls – Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate, U.S. Food and Drug Administration
• FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis, U.S. Food and Drug Administration
• NaturaLyte Liquid and Granuflo Acid Concentrate Bicarbonate Alkalosis, Fresenius Medical Care North America
• “Dialysis Patient Survival Is Better at Fresenius Medical Care Clinics Because … — Part I,” RenalWEB
• “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry,” New York Times