GranuFlo is a product that FMC developed to help save money on their dialysis mixture. This is a dry acid concentrate product that could be shipped from the manufacturer in powder form, and then mixed on site with purified water and bicarbonate to be used in the dialysis machines.
Before GranuFlo the acid component of a dialysate bath was acetic acid. This acid was typically produced in liquid form that was pre-packaged with purified water and delivered to the clinics in a large drummer container. Obviously, it was much more difficult, and costly (the key word here) to ship, store, and maintain large drums of liquid on or off site for the dialysis clinics.
Once Fresenius saw that the dry acid product could be shipped and then mixed on site, it immediately jumped at the opportunity to obtain a patent for this product which could increase their profits and help them to maintain control of the dialysis industry. The FDA approved the product and Frensenius was on its way to making money.
The only benefit to producing and shipping the dry GranuFlo, and having it mixed on site, is to save money in shipping and storage cost. Using GranuFlo was never going to be a safer avenue for the patients…and in fact we recently found out that not only was it not as safe, but it was extremely dangerous.
On March 3, 2012 a “whistle blower” provided a package to the FDA containing an internal Fresenius memorandum that had been sent to the FMC medical directors in November 2011. This memo warned of the dangers of the increase bicarbonate levels that were caused by GranuFlo, and reported that their studies had shown that these elevated bicarbonate levels were causing a 6 to 8 times increase in cardiac arrest and deaths. In other words, GranuFlo knew of the dangerous propensities of its product, but failed to say anything for five months, and probably would have never said anything had this brave whistle blower not come out.
The FDA recently issued a warning and recall of this dangerous product. If you or a member of your family was suffered any injury including cardiac arrest, stroke, or even death following dialysis, please contact the attorneys at Hogan Frick immediately so we can obtain your medical records and determine if this dangerous product was used.