The U.S. Food and Drug Administration (FDA) is investigating the timing related to a voluntary recall of the bicarbonate product, GranuFlo, manufactured by Fresenius Medical Care Holdings, Inc (FMCH). This product allegedly puts dialysis patients at an increased risk of cardiac arrest.
The "voluntary recall" does not remove GranuFlo from dialysis centers, but is an alert to all medical providers engaged in dialysis that additional precautions are necessary.
GranuFlo Dry Acid Concentrate is a bicarbonate product that dialysis centers around the country rely heavily upon (including locally in Sacramento, California) and is suspected in the increased cardiac-related deaths of dialysis patients nationwide.
When improperly administered, a four- to six-fold increased risk of cardiac arrest occurs — a little known fact until internal studies citing the risks were found to be in the manufacturer's possession.
FMCH is alleged to have known that an increased risk of cardiac arrest was associated with higher concentrations of its products resulting in abnormally high blood levels of bicarbonate. It is accused of failing to alert outside dialysis centers in a timely manner.
Its alleged inaction is suspected in the cardiac-related deaths of a still unknown number of dialysis patients whose blood levels of bicarbonate became lethal during dialysis.
Internal Studies Prove Granuflo Risk Factors
As a New York Times article explains (June 14, 2012), in addition to manufacturing dialysis machines, disposable products and bicarbonate concentrates, FMCH is the largest operator of privately owned dialysis centers in the U.S.
Fresenius Medical Care sent an internal memo to doctors throughout the company's own dialysis centers on Nov. 4, 2011, warning that higher blood bicarbonate levels "...appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest."
Specifically, the internal memo cited 941 patients who had suffered cardiac arrest within Fresenius' own facilities in 2010. When compared with other patients, high levels of bicarbonate in the bloodstream resulted in up to six times the risk of cardiac arrest.
Fresenius' medical office, however, did not issue the same warning to independent dialysis centers throughout the country that use the product.
It's been estimated that 125,000 patients are treated with GranuFlo in non-FMCH, independent and community dialysis facilities in the U.S.
Only after the memo was sent anonymously to the FDA, which in turn began to question the manufacturer, did FMCH issue a voluntary warning (recall) nationwide in March 2013.
What To Do If You Have Experienced A Cardiac Event While On Dialysis
If you or a loved one is a dialysis patient who has suffered a cardiac-related event and suspect GranuFlo Dry Acid Concentrate was involved, please contact us toll free at 888-285-3333 to schedule a free consultation or complete the contact form below.