Medical Devices
GranuFlo and NaturaLyte
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If you suffer from poor kidney function or kidney loss, you rely on dialysis to help remove toxins from your blood and maintain important mineral balances. However, the use of acid concentrates such as GranuFlo and NaturaLyte as part of the mineral balancing process has been linked to severe and sometimes fatal heart conditions.
GranuFlo and NaturaLyte Injuries
The following injuries or side effects have been reported by dialysis patients who were treated with GranuFlo or NaturaLyte:
- Cardiac arrhythmia (irregular heartbeat)
- Cardiopulmonary arrest
- Hypercapnia (high levels of carbon dioxide in the blood)
- Hypokalemia (low levels of potassium in the blood)
- Hypoxemia (low levels of oxygen in the blood)
- Metabolic Alkalosis
- Stroke
- Sudden cardiac death
On March 29, 2012, the FDA initiated a Class 1 recall for NaturaLyte and GranuFlo because of their potential to cause cardiopulmonary arrest in dialysis patients. According to the FDA, "Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
GranuFlo and NaturaLyte History
GranuFlo and NaturaLyte are products that control acid, sodium, potassium, calcium and magnesium levels in a dialysis patient's blood. These products are manufactured by Fresenius Medical Care, the world's largest supplier of dialysis machines, which operates more than 2,700 dialysis centers worldwide. In the United States, Fresenius manages more kidney dialysis clinics than any other company, treating more than 130,000 patients. In addition, it is estimated that approximately 100,000 patients have been treated with GranuFlo and NaturaLyte in non-Fresenius clinics.
On Nov. 4, 2011, Fresenius sent an internal memo to its clinic doctors and medical directors warning them that NaturaLyte Liquid or GranuFlo may pose a greater risk for cardiopulmonary arrest and sudden cardiac death in certain patients. The memo detailed the potential dangers associated with GranuFlo and NaturaLyte, showing that 941 patients suffered cardiac arrest while being treated at Fresenius clinics in 2010.
Fresenius did not initially warn any other doctors or patients at non-Fresenius clinics or the general public about these risks. After the FDA anonymously received the Fresenius internal memo in late March 2012, the agency initiated the Class 1 recall to make sure that every patient knows of the potential dangers associated with GranuFlo and NaturaLyte. The FDA is now investigating Fresenius to determine whether the company violated federal law by failing to warn all patients of the serious risks connected to GranuFlo and NaturaLyte.
