As the flow of GranuFlo lawsuits continues unabated, GranuFlo manufacturer Fresenius Medical Care was cited for deficiencies in one of its facilities.
A recent report carried by the Birmingham News indicated that two deaths occurred while patients were receiving hemodialysis treatments at the Bessemer Kidney Center in Bessemer, Alabama. An additional five patients had to be hospitalized. The Bessemer Kidney Center is owned by Fresenius Medical Care, one of the largest operators of dialysis centers in the United States. The company remains under a cloud stemming from a large-scale recall of the GranuFlo and NaturaLyte solutions.
Records from Alabama show the facility was cited in 2012 for failure to meet standards associated with infection control, use of gloves and the disinfection of all surfaces. The deficiencies have been corrected, but recent deaths and hospitalizations resulted in the facility being shut down pending further investigation. Initial review has not indicated any direct links between all seven cases.
While Fresenius deals with the fallout from the shuttered dialysis center, it continues to deal with dosing errors related to GranuFlo and NaturaLyte. The two products are used as a part of the dialysis treatment, and work well when dosing remains at optimum levels and are monitored for bicarbonate in the blood. Failure to monitor levels of bicarbonate in the blood can lead to cardiac events. Fresenius used an internal memo to alert only the dialysis centers operated by Fresenius about potential alkali dosing errors leading to incorrect levels of bicarbonate in the blood.
Carbon dioxide is a gaseous waste product from the metabolism of energy. Blood carries carbon dioxide to your lungs, where it is then exhaled into the atmosphere around you. More than 90% of the carbon dioxide that is in your blood exists as bicarbonate (HCO3). The rest of the carbon dioxide is either dissolved carbon dioxide gas or carbonic acid. Your kidneys and lungs act to balance the levels of carbon dioxide, bicarbonate and carbonic acid in the blood. Bicarbonate acts as the chemical buffer responsible for keeping the pH of blood from becoming too acidic or too basic, both of which cause severe physical problems for a dialysis patient.