An excessively high level of carbon dioxide in the blood is one of the main health risks associated with Fresenius Medical Care’s (FMC) GranuFlo and NaturaLyte acid concentrates. Findings from a 2010 internal study found that the acetic acid and sodium acetate formulation used in GranuFlo and NaturaLyte converted into bicarbonate at greater levels than alternative acid concentrates that only used acetic acid. As such, patients were at risk of being dosed with greater levels of bicarbonate than prescribed.

What is Bicarbonate?

Bicarbonate is the form carbon dioxide takes when the compound enters the blood stream. Because bicarbonate is alkaline, it functions in the bloodstream as a vital component of the pH buffer. The blood is regulated within a narrow range, between 7.35 and 7.45, at slightly alkaline levels. When the blood becomes too basic, bicarbonate is quickly converted into carbonic acid to lower the pH, and when the pH is too low, carbonic acid is converted into bicarbonate to raise the pH back to homeostasis. Maintaining a constant pH is critical for protecting the tissues throughout the body.

Side Effects from High Levels of Bicarbonate

Metabolic alkalosis is a condition where the pH is raised above the normal range maximum of 7.45. This is extremely dangerous for patients undergoing hemodialysis because the patient’s damaged for failed kidneys can do nothing to filter the excess bicarbonate out of the blood stream. Elevated levels of bicarbonate has been strongly associated with serious health complications such as:

  • Cardiac arrhythmia
  • Hypercapnia
  • Hypoxemia
  • Low blood pressure
  • Hypokalemia

Hemodialysis for Kidney Patients

The kidney serves to filter all of the waste and excess water out of the blood, when both kidneys fail or are too damaged to function properly, hemodialysis can prolong a patient’s life by artificially filtering the blood three times a week. The process draws the patient’s blood out and into a dialysis machine, where the blood and dialysate is circulated in opposite directions against a permeable membrane. In the machine, the waste is removed and a prescribed dose of bicarbonate diffused into the blood before reentering the body. Until the next dialysis session, the patient will be unable to filter any excess or waste out of his or her bloodstream. Making it essential that each dialysis treatment provides the patient with the proper dose of bicarbonate.

GranuFlo and NaturaLyte Recall Attorneys

Although GranuFlo was introduced to the U.S. market in 2003, because of the lack of any clinical trials or case studies, the formula’s high bicarbonate conversion rates were left unknown to the public until 2012. If you or a loved one has suffered from carbon dioxide poisoning linked to the GranuFlo or NaturaLyte acid concentrates, make sure to speak with a skilled product liability lawyer regarding your potential case. Estey & Bomberger attorneys are currently screening GranuFlo and NaturaLyte carbon dioxide poisoning cases to help wrongfully injured patients seek justice against a negligent medical device manufacturer. To schedule a free consultation, please contact us today on our 24/7 hotline or on our website.