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Fresenius Medical GranuFlo & NaturaLyte Acid Concentrate Dialysis Treatment Recall Lawsuit

The Attorneys of Ennis & Ennis, P.A. are currently pursuing potential lawsuits for individuals who have experienced injury or loss due to cardiovascular death, sudden cardiac death, cardiopulmonary arrest, heart attack, and other catastrophic cardiovascular injuries after being administered GranuFlo or NaturaLyte during recent dialysis treatments.

The Naturalyte and Granuflo Dry Acid Concentrate 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.

Fresenius Medical Care, the maker of GranuFlo and NaturaLyte is currently facing investigation by the U.S. Food and Drug Administration over heart attack and other cardiac events risks associated with GranuFlo.

Dialysis is a procedure that clears toxic waste from the blood in patients whose kidneys have failed. In dialysis, bicarbonate is administered to neutralize the acid that builds up in the blood.

Fresenius Medical Care’s GranuFlo contains an ingredient that the converts to bicarbonate at higher levels than its rival products. This may cause dangerous bicarbonate levels in patients.

What is the problem?

Fresenius manufactures two products used in dialysis, GranuFlo and NaturaLyte. Both of these dialysis products have been linked to causing alkalosis, a condition associated with an increase in cardiovascular events.

The FDA received complaints describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.

This can contribute to metabolic alkalosis, which is a significant risk factor associated with :

  • Low blood pressure
  • Cardiopulmonary arrest
  • Cardiac arrhythmia
  • Sudden heart attack
  • Stroke
  • Hemodialysis cardiopulmonary arrest

A study which was conducted between January and December of 2010 found that patients with pre-dialysis bicarbonate levels greater than 28mEq/L were 4.7 times more likely to suffer a cardiac arrest. The study also discovered that patients with pre-dialysis potassium lower than 4 mEq/L had a 6.3 times higher risk of cardiac arrest.

In May 2012 the FDA notified health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients’ dialysate prescription.


GranuFlo and NaturaLyte Class 1 Recall

In late June 2012 a class 1 recall was issued by Fresenius Medical Care North America where they stated the reason for the recall as follows:

"The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius' Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death."

The FDA also issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.

Serial numbers for recalled Naturalyte Liquid Acid Concentrate range from:

08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-1

Serial numbers for recalled Naturalyte GranuFlo (powder) Acid Concentrate range from:

OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B

Failure to Warn

In November of 2011, Fresenius medical sent an internal memo to doctors who practiced in the company’s dialysis centers, warning them that failure to properly use GranuFlo appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest. The memo also stated “In light of these troubling findings, doctors should take corrective action." “This issue needs to be addressed urgently,” the memo added later.

Despite these risks, Fresenius Medical failed to issue any type of warning to its customer clinics until March 2012. It only did so after the FDA received a copy of the company’s internal memo from an anonymous source and contacted Fresenius Medical to inquire about it.

GranuFlo & NaturaLyte is one of the most widely prescribed dry acid products in the dialysis industry today and is used at Fresenius' own clinics, as well as other hemodialysis centers that purchase their dialysis supplies from Fresenius Medical Care. It is estimated that roughly 125,000 patients in non-Fresenius clinics are treated with GranuFlo.

Fresenius GranuFlo Time Line

May 2003: Fresenius Medical Care’s GranuFlo and NaturaLyte dialysis concentrates receive FDA 510(k) clearance.  GranuFlo concentrate is a dry acid solution with a higher concentration of the chemical that products bicarbonate during dialysis.  Elevated bicarbonate levels can cause sudden cardiac arrest and other heart problems.

2004-2011: Patients’ bicarbonate levels steadily increase.  

2010: Fresenius conducts a study on patients receiving hemodialysis treatment at 667 Fresenius facilities and compares the patients’ bicarbonate levels to the bicarbonate levels of over 80,000 patients receiving dialysis in the same centers.  

November 4, 2011: Fresenius sends an internal memo to its own clinics warning of the significant risk of  cardiopulmonary arrest, noting that 941 hemodialysis patients using GranuFlo and NaturaLyte concentrates suffered cardiac arrest in 2010.  The memo recommends that “in light of the troubling findings”, physicians should individualize dialysate bicarbonate prescriptions.

Early 2012:  The FDA receives anonymous copy of the November internal memo.
March 29, 2012:  FDA initiates a recall of GranuFlo and NaturaLyte concentrates manufactured and distributed from January 2008 through June 2012.  This is when Fresenius Medical Care, together with the FDA, first notifies the non-Fresenius facilities of the dangers associated with the Fresenius products.

May 25, 2012: FDA issues a Safety Communication addressing the GranuFlo and NaturaLyte dosing errors with hemodialysis treatment noting the higher risk of death.

Free GranuFlo - NaturaLyte Dialysis - Metabolic Alkalosis - Cardiac Side Effects Lawsuit Case Evaluations

If you or a loved one have suffered serious NaturaLyte or GranuFlo side effects, suffered a loss due to GranuFlo or NaturaLyte Cardiac Side Effects or have been injured as a result of a metabolic alkalosis you may be entitled to compensation. Contact the GranuFlo - NaturaLyte Recall Injury Lawyers of Ennis & Ennis today for a free confidential case evaluation by filling out the form on this page or call toll-free: 1-800-856-6405.

More GranuFlo - NaturaLyte Acid Concentrate Recall Lawsuit Attorney News::


Ennis & Ennis, P.A. is currently handling cases for GranuFlo and NaturaLyte Acid Concentrates:

GranuFlo Recall

NaturaLyte Recall

Fresenius Dialysis Injury Lawyer

Metabolic Alkalosis

GranuFlo Lawsuit

NaturaLyte Lawyer

Cardiac Arrest

Sudden Death

Side Effects Attorney

Dialysis Injury Lawyer

If you or a loved one have suffered serious GranuFlo or NaturaLyte side effects, suffered a loss due to GranuFlo or NaturaLyte Cardiac Side Effects or have been injured as a result of a metabolic alkalosis you may be entitled to compensation. Contact the GranuFlo - NaturaLyte Acid Concentrate Recall Lawyers of Ennis & Ennis today for a free confidential case evaluation by filling out the form on this page or call toll-free:1-800-856-6405.






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