Fresenius Medical is the manufacturer of GranuFlo and NaturaLyte acid concentrate. These are drugs used in dialysis treatment. There has been a recall of these dialysis drugs and lawsuits are being filed.

Injury and death has resulted from these drugs:

• GranuFlo cardiovascular death,
• GranuFlo sudden cardiac death,
• GranuFlo cardiopulmonary arrest,
• GranuFlo heart attack,
• GranuFlo catastrophic cardiovascular injuries

Fresenius manufactures GranuFlo and NaturaLyte used in dialysis. These drugs cause alkalosis, a condition associated with an increase in cardiovascular fatalities.

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.

There is a GranuFlo and NaturaLyte Class 1 Recall

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-

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

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

Dilaysis Patient Alert

If you, a loved one or someone you care for has been injured by these products contact us for a GranuFlo and NaturaLyte lawsuit.