Fresenius (FMC) neglected to warn the public about the risks of using GranuFlo. An internal memo issued by Fresenius on November 4, 2011, disclosed that there was a significant risk of cardioplumonary arrest and death for patients undergoing dialysis treatment at their clinics due to the incorrect dialysate concentration. This information was only shared with physicians and clinics associated with FMC. According to their report, 941 patients treated at FMC clinics had cardiac arrests during or shortly after treatment. The thousands of other clinics that were using these products were not notified of the problem until March 2012. The FDA is currently undergoing an investigation to see if Fresenius’ failure to issue an earlier warning violates federal law.
What Should You do if You or a Loved One Uses GranuFlo
If you or a loved one use GranuFlo for dialysis treatments, discuss the danger of bicarbonate overdosing with your medical professional. This risk has been associated with sudden heart attacks and even death in hemodialysis patients. Be sure you understand how your hemodialysis device mixes GranuFlo and have your doctor review the labeling for the specific concentration they have prescribed.
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You may have a claim against the manufacturer of GranuFlo, Fresenius Medical Care. Fill out the contact form on this page if you or a loved one, have used GranuFlo and suffered from a heart attack or death during or after dialysis treatment. You will receive a free consultation from a GranuFlo lawyer to help you determine whether or not you may wish to pursue a claim.
Remember, this manufacturer was aware of the risk of serious heart issues and death but chose not to share this information with the public or the FDA until the memo was leaked. As a result, your GranuFlo lawyer will fight to get you compensation for your additional medical costs, rehabilitation, loss of income and any other claims that may apply to your case. Use the convenient form on this page for your free consultation. There may be a time limit to apply for compensation for your injuries so be sure to send in the form today for your free consultation.
On June 17, 2012, the U. S. Food and Drug Administration (FDA) issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. These products are used for patients undergoing hemodialysis. A Class I Recall is the most serious of FDA recalls and only issued when the use or exposure of the recalled item will cause serious adverse health consequences or death. As a result of the recall, thousands have learned that they or their loved ones might have a valid claim against the manufacturer, Fresenius (FMC).
Why Did the FDA Issue a Class I Recall?
Naturalyte and GranuFlo are available by prescription and are additives (dialysates) used in dialysis treatment to counteract the rising acidity levels. Both Naturalyte and GranuFlo are formulated to be used with a three stream hemodialysis machine and dialyzer to remove wastes from the blood. If not used in the proper dosage, these additives can result in grossly elevated levels of bicarbonate. This leads to a pH imbalance that can ultimately interfere with bodily functions and cause heart attacks and even death.
GranuFlo contains a powdered form of acetic acid which the dialysis clinics then mix to form the dialysate solution used for treatment. The FDA received a complaint that the directions for mixing and using GranuFlo were incomplete and put the patients at risk of bicarbonate overdosing. This may lead to metabolic alkalosis, a significant risk factor of low blood pressure and cardiac arrhythmia which if not immediately treated could result in a stroke or heart attack. The patient could die shortly after completing dialysis treatment with GranuFlo.
What is Dialysis?
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIH), dialysis is used to replace the work of kidneys. Healthy kidneys clean your blood and make hormones that keep bones strong and your blood healthy. If kidneys fail, you will need either a kidney transplant or dialysis treatment.
There are two main types of dialysis treatment: hemodialysis and peritoneal dialysis. Both filter the blood ridding the body of harmful wastes, extra salt and water. Peritoneal dialysis filters using the lining of the abdomen (peritoneal membrane) and hemodialysis is done with a machine.
Naturalyte and GranuFlo are used with a hemodialysis machine to remove wastes from the blood. The concentrate prescribed is then mixed with purified water to make the correct chemical balance as determined by the doctor. This fluid is called dialysate or “bath”. The dialysis machine controls the flow of the blood. Wastes and fluid from the blood goes into the bath and are drained away. Normally no more than two cups of blood will be outside the body during dialysis.
GranuFlo and Naturalyte are prescribed for use in the treatment of acute and chronic renal failure during dialysis. The concentrated products are manufactured by the German company, Fresenius (FMC). Over 100,000 patients have used GranuFlo at around 5700 FMC sponsored and other clinics in the United States with estimated revenue of over $80 million.
GranuFlo contains a powdered form of acetic acid mixed at the dialysis clinics to form the dialysate solution needed for treatment. The FDA received reports that the directions for mixing and using GranuFlo were incomplete and put patients at risk of bicarbonate overdosing which could result in death.
Risks Associated With the Use of GranuFlo
According to the FDA recall, GranuFlo’s concentration of acetate or sodium diacetate can lead to a too high serum bicarbinate level while undergoing dialysis. This can lead to the following:
- low blood pressure
- hypokalemia (low potassium)
- hypoxemia (low blood oxygen)
- cardiac arrhythmia
- cardiac arrest
Many patients suffered adverse health effects due to the inappropriate dosing errors of GranuFlo while still at the dialysis clinic or shortly after treatment.