GranuFlo®

If you or someone you love is a dialysis patient who has suffered heart attack or cardiopulmonary arrest, GranuFlo® acid concentrate may be to blame. GranuFlo® is a product used in hemodialysis treatments. GranuFlo® use can lead to metabolic alkalosis, heart attack, and death.

GranuFlo® Injuries and Death

In hemodialysis it is necessary to neutralize the excess acid in the blood. However, GranuFlo® defects can easily lead to improper dosing resulting in blood that is too alkaline. When this occurs it can cause:

  • Cardiopulmonary arrest
  • Heart arrhythmias
  • Stroke
  • Heart attack
  • Sudden cardiac death

GranuFlo® injuries can be fatal and those who survive may suffer secondary injuries, such as brain injury from lack of oxygen to the brain during a cardiac event, and permanent disabilities.

Intentional Failure to Warn

GranuFlo® maker, Fresenius Medical Care (FMC), operates the largest chain of hemodialysis clinics in the U.S. as well as selling hemodialysis products to non-FMC clinics.

When FMC informed its own clinics of the dangers of GranuFlo®, it chose not to contact customer clinics using the products, and might have waited indefinitely had it not been for an anonymous whistleblower who leaked the information to the U.S. Food and Drug Administration (FDA).

The FDA is investigating whether Fresenius violated federal regulations when it failed to warn customer clinics.

FMC sent a memo, dated November 4, 2011, to its clinics warning of the dangers of the acid concentrate, how to identify at-risk patients, and steps to take to prevent GranuFlo® dialysis injury.

The memo explained that 941 patients suffered cardiopulmonary arrest in 677 of its clinics in the year 2010, and that after comparing the data on patients who suffered cardiopulmonary arrest to those who did not, FMC’s medical staff found that patients with elevated levels of bicarbonate were six times as likely to suffer cardiac arrest as those with normal levels.

It is estimated that nearly half of all patients who receive GranuFlo®, about 125,000 patients, receive dialysis treatment in non-FMC clinics; clinics that FMC chose not to inform about the dangers.

GranuFlo® Recall

In March, 2012, an anonymous source leaked the memo to the FDA. After the FDA questioned FMC about the memo, the company contacted its customers about the dangers of GranuFlo® and issued a recall of both GranuFlo® and NaturaLyte® acid concentrate.

The communication FMC sent to its customers still did not contain the level of detail and useful instructions that it had sent to its own clinics.

If you or a loved one has suffered a heart attack or another cardiovascular event which you believe was caused by GranuFlo®, please find a local GranuFlo® injury attorney right away, and schedule a consultation to learn about the compensation that you and your family may be able to recover.