Product name: Granuflo
Manufacturer: Fresenius Medical Care
Uses: Dialysis employs a machine to replicate the functions of healthy kidneys for patients in the later stages of kidney failure. The process includes using bicarbonate to neutralize acids that accumulate in the blood. Granuflo is a powdered form of that bicarbonate.
Malfunction: A risk of causing sudden, and potentially deadly, heart attacks.
Granuflo is a powdered form of the bicarbonate used in kidney dialysis. While it isn’t more effective than the previously used liquid form, it’s less expensive to store and transport.
In June, 2012, the FDA issued a Class 1 recall of the product, warning that it could cause “serious adverse health consequences, including death.”
But internal documents showed that manufacturer Fresenius Medical Care was aware of the risk for months — possibly years — before the federal recall, yet allowed the product to be administered to unsuspecting patients.
In November, 2011, Fresenius sent a warning to doctors in its own clinics, warning them that Granuflo was the likely cause of nearly 1,000 episodes of cardiac arrest.
But Fresenius did not inform other clinics using its products until an anonymous tipster notified the U.S. Food and Drug Administration of the in-house warning in March, 2012.
Further investigation indicates that Fresenius knew of the problem much earlier, and knowingly put thousands of people at risk of deadly heart attacks.
FDA Investigates Granuflo Maker
The U.S. Food and Drug Administration is investigating whether the German company Fresenius Medical Care kept quiet about the possibility that one of its products could cause fatal heart attacks.
An article in the New York Times says Fresenius operates dialysis centers. In addition to treating more than a third of the estimated 400,000 Americans who receive dialysis, it is also the country�s leading supplier of machines and disposable products used in the process.
In November, 2011, Fresenius sent an internal memo to doctors practicing in dialysis centers that the company operates. The memo said 941 patients suffered cardiac arrest inside Fresenius clinics in 2010, and a product called Granuflo may be responsible.
But until the F.D.A. received a copy of the internal memo from an anonymous tipster in March, 2012, Fresenius informed nobody else about the health hazard.
The New York Times says an estimated 125,000 patients at outside clinics continued to get treated with Granuflo as Fresenius sat on that information.