GranuFlo and NaturaLyte Dialysis Products
On March 29, 2012, the United States Food and Drug Administration (FDA) issued a recall for 2 dialysis products known as GranuFlo and NaturaLyte after dialysis patients who received such products suffered cardiopulmonary arrest. The recall was a Class 1 recall, which is the most serious type of recall. It is utilized when there is a reasonable probability that the use of the product will cause serious injuries or death.
These products are manufactured by Fresenius Medical Care, one of the world’s biggest suppliers of dialysis machines. In the U.S. alone, Fresenius manages more dialysis clinics than any other company, and treats in excess of 130,000 patients. GranuFlo and NaturaLyte were used by Fresenius in their dialysis clinics. However, it has been estimated that another 100,000 patients may have been treated with GranuFlo and NaturaLyte in dialysis clinics that were not owned or managed by Fresenius.
It has been reported that Fresenius sent an internal memo to its dialysis clinic doctors and medical directors, informing them that GranuFlo and NaturaLyte liquid may result in certain patients having an increased risk for cardiac arrest. The memo revealed that 941 patients had experienced cardiac arrest while being treated at dialysis clinics owned by Fresenius in the year 2010. Fresenius failed to warn other doctors, medical directors, and patients at dialysis clinics that were not owned by Fresenius, and failed to initially warn the general public about these increased risks associated with GranuFlo and NaturaLyte. The FDA is investigating Fresenius for its alleged failure to warn all patients of the serious risks associated with GranuFlo and NaturaLyte.
A number of injuries or side effects have been reported by dialysis patients who received GranuFlo or NaturaLyte. They include:
- Sudden cardiac death
- Cardiopulmonary arrest
- Cardiac arrhythmia (an irregular heartbeat)
- Hypoxemia (low levels of oxygen in the blood)
- Hypokalemia (low levels of potassium in the blood)
- Hypercapinia (high levels of carbon dioxide in the blood)
On February 27, 2013, a lawsuit was filed against Fresenius Medical Care North America in Federal Court in Boston, Massachusetts on behalf of the widow of a patient who suffered a heart attack and died following dialysis treatment using GranuFlo. The lawsuit alleges that Fresenius failed to warn that the use of GranuFlo during dialysis puts patients at an increased risk of cardiac arrest, sudden cardiac death and stroke. The lawsuit also alleges that Fresenius knew about the risks for years before the victim underwent his dialysis treatment. The plaintiff is seeking compensatory and punitive damages for the death of her husband.
The Suthers Law Firm is investigating and reviewing potential cases against Fresenius on behalf of dialysis patients who were treated with GranuFlo or NaturaLyte and suffered injuries, such as sudden cardiac death, cardiopulmonary arrest, cardiac arrhythmia, or stroke. If you suspect that you or a loved one has been injured by GranuFlo or NaturaLyte, call the Suthers Law Firm toll-free at 800-320-2384 or contact us online for a free consultation.