GranuFlo Dry Acid Concentrate and NaturaLyte Liquid Acid Concentrate are medical products used during hemodialysis, which is the removal of wastes from the blood of patients who suffer from acute and chronic renal (kidney) failure.

Because calorie and protein malnutrition is a common problem among dialysis patients, amino acids are added to the solution that patients receive during treatment.

Fresenius Medical Care North America of Waltham, Massachusetts, began manufacturing and distributing GranuFlo and NaturaLyte dialysis products in January 2008.

Problems with GranuFlo and NaturaLyte

In March 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall of GranuFlo Dry Acid Concentrate and NaturaLyte Liquid Acid Concentrate. Class I recalls are the most serious type of recall. This type of recall involves situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death, the FDA says.

The FDA said GranuFlo and NaturaLyte can contribute to elevated bicarbonate levels in hemodialysis patients if used improperly, which can cause metabolic alkalosis, a pH imbalance in which the body has accumulated too much of an alkaline substance.

Metabolic alkalosis is a significant risk factor associated with:

  • Cardiopulmonary arrest (heart attack).
  • Cardiac arrhythmia (irregular heart rate)
  • Hypoxemia (low blood oxygen)
  • Hypercapnia (increased carbon dioxide in the blood)
  • Hypokalemia (low potassium levels in the blood)
  • Hypotension (low blood pressure).

Severe metabolic alkalosis that is left untreated will lead to convulsions, heart failure and coma.

In June 2012, The New York Times reported that Fresenius had alerted its own physicians and medical directors in November 2011 that GranuFlo “appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.”

But the manufacturer did not advise the public or the FDA about medical problems associated with GranuFlo or NaturaLyte until the FDA received a copy of the Fresenius memo and inquired about it in March 2012.

Have You Been Injured By GranuFlo or NaturaLyte? Contact Our Lawyers Today

The Legal Team of Cohen and Malad, LLP, is investigating cases of injury and wrongful death attributed to the administration of GranuFlo Dry Acid Concentrate or NaturaLyte Liquid Acid Concentrate during hemodialysis.

Cohen and Malad, LLP, are nationally recognized law firms experienced with personal injury and wrongful death lawsuits based on drug injury and defective medical products.

If you or a loved one has suffered complications after administration of GranuFlo Dry Acid Concentrate or NaturaLyte Liquid Acid Concentrate during hemodialysis, including cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia or cardiac arrhythmia, you may have a legal right to compensation.

Protect your rights! Don’t delay!

Contact the legal team of Cohen and Malad, LLP, today by calling us toll free or use our online form. We can provide you with a free, no obligation consultation.

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