GranuFlo & NaturaLyte

Suffering by Dialysis Patients May Have Been Avoided

On June 27, 2012, the FDA issued a recall for Fresenius Medical Care North America's products, GranuFlo and NaturaLyte, due to the risk of heart attacks.  Patients who received hemodialysis treatment with GranuFlo or NaturaLyte between 2008 and 2012 and suffered cardiovascular death, heart attack or other limited catastrophic injures within 24 hours of receiving the dialysis treatment may have a claim.

Apparently in 2010 top Fresenius executives knew of the increased risk of cardiac arrest and death during dialysis treatment associated with GranuFlo dialysis products. Facilities that used GranuFlo products include Fresenius, DaVita, and other hospitals and clinics.

If you or a loved one have suffered any of the following side effects, the injury may have been caused by dialysis products that were used in many dialysis centers despite risks only the manufacturer knew about:

  • Low blood pressure (hypotension)
  • Heart attack or myocardial infarction
  • Heart Problems
  • Cardiopulmonary arrest
  • Metabolic alkalosis
  • Stroke
  • Death

Was Public Misled?

Fresenius Medical Care (FMC) manufactures GranuFlo and NaturaLyte, as well as many of the machines and products used in dialysis treatments. FMC is also one of the largest dialysis clinic operators in the world. In 2011, FMC issued an internal notice to its company-owned clinics, warning of the risks and side effects of the products; however, they failed to offer warnings to thousands of physicians and clinics not owned by FMC who continued to use their product.

Because of serious GranuFlo® and NaturaLyte® side effects, the U.S. Food and Drug Administration (FDA) has announced a Class 1 recall on the dialysis products. The two potentially dangerous pharmaceuticals are acid concentrates diluted to become a component of dialysate, which is used to clean the blood of patients undergoing hemodialysis for treatment of renal (kidney) failure.

If you or a loved one is undergoing dialysis, take these steps immediately:

  • Protect yourself by reviewing patients at most at risk.
  • Ensure that your physician is properly formulating yours—or your loved ones—dialysate at your clinic.

Findings behind the recent Class 1 recall of GranuFlo® and NaturaLyte® point to the dialysis risks of metabolic alkalosis—or high bicarbonate levels:

  • Both GranuFlo and NaturaLyte contain sodium diacetate, which increases bicarbonate beyond the prescribed levels.
  • Metabolic alkalosis, or high bicarbonate levels, can cause heart attack, cardiac arrest, stroke, low blood pressure and even death.
  • All patients who are undergoing treatment have higher dialysis risks when using GranuFlo and NaturaLyte, though some patients are even more susceptible to elevated bicarbonate levels—causing a bicarbonate overdose.

If you suspect that either GranuFlo or NaturaLyte is or was being used to formulate yours or your loved ones dialysate, immediately speak to your doctor.

If you or a loved one has suffered from a heart attack, cardiac arrest, stroke, low blood pressure or death while receiving dialysis, GranuFlo or NaturaLyte products may be at fault. Contact our firm to discuss your situation.