NaturaLyte®

In March, 2012, Fresenius Medical Care (FMC) recalled its NaturaLyte® and GranuFlo® acid concentrate dialysis products. FMC operates the largest chain of dialysis clinics in the U.S., treating about one-third of dialysis patients in the country, and its dialysis products are sold to and used in non-FMC clinics as well. NaturaLyte® was recalled because it can cause cardiopulmonary arrest, heart attack, and death.

Hemodialysis

Hemodialysis is a life-saving treatment for people with acute or chronic renal failure. Dialysis does not repair the kidneys, but it performs some of the functions of the kidneys. In dialysis, waste products are filtered out of the blood.

A typical schedule for hemodialysis treatment is three sessions a week, lasting about three to five hours per session.

Improper Dosing

Improper dosing is highly likely when using NaturaLyte® and, before the recall, doctors were not warned of the danger and how to avoid the problem.

During dialysis treatment excess acid in the blood is neutralized. Acid concentrate used in dialysis is converted to bicarbonate in the body, and doctors prescribe additional bicarbonate to restore the blood to its proper pH.

NaturaLyte® acid concentrate contains acetate, which creates more bicarbonate in the body than ingredients in similar products. This can lead to improper dosing, bicarbonate overdose, and blood which is too alkaline, creating a life-threatening condition called metabolic alkalosis.

Metabolic Alkalosis

Dialysis patients, treated with NaturaLyte® can suffer heart attacks and die before even leaving the dialysis clinic. Metabolic alkalosis can cause multiple problems in the body which can culminate in fatal cardiac events if the condition is not treated quickly. Metabolic alkalosis can cause:

  • Low blood pressure
  • Cardiac arrhythmia
  • Low blood-oxygen (hypoxemia)
  • High carbon dioxide in the blood (hypercapnia)
  • Low potassium (hypokalemia)
  • Heart attack
  • Cardiopulmonary arrest
  • Sudden cardiac death

Symptoms of metabolic alkalosis can include:

  • Rapid heart rate
  • Irregular heart beat
  • Twitching
  • Nausea
  • Vomiting
  • Diarrhea
  • Irritability
  • Confusion
  • Drop in blood pressure
  • Slowed breathing
  • Cyanosis – blue or purple coloring of the skin or under the fingernails
  • Episodes of apnea (not breathing) which may last 15 seconds or longer
  • Convulsions
  • Coma

If you are a dialysis patient and have suffered a heart attack or cardiopulmonary arrest, or if you have lost a loved one to a heart attack or another cardiac event caused by a defective dialysis product, you may be entitled to compensation. A NaturaLyte® injury attorney in your area can help. Please schedule a consultation today.