Fresenius Medical Care manufactured GranuFlo and NaturaLyte dialysates used for dialysis in patients suffering from chronic kidney disease and renal failure. The Food and Drug Administration (FDA) approved GranuFlo in 2003 through a process called 510(k) of the Food, Drug, and Cosmetic Act. In this process, a premarketing submission is made which says that the device is substantially equivalent to a device already placed on the market.
Fresenius made a claim that GranuFlo was “substantially equivalent” to its dialysates which were already on the market since the 1990s; it was the first time when Fresenius had begun using sodium diacetate; however, in 1994, Fresenius increased the amount of sodium diacetate. Quite evidently, all the other dialysates had got approval in a similar way by FDA’s 510(k) process.
Fresenius issued an internal memo on November 4, 2011. According to this memo, more than 900 patients experienced heart attacks in Fresenius clinics during the previous year. Very strategically, this memo was sent only to Fresenius’ dialysis centers, and other centers were not informed.