The GranuFlo dialysis dry acid concentrate is a product used for treatment of patients with acute and long lasting renal failure while undergoing hemodialysis. This special concentrate is made for use with a three-stream hemodialysis mechanism, that is supposed to be calibrated for both bicarbonate and acid concentrates.
The maker of GranuFlo dialysis products, Fresenius Medical Care, is currently being investigated by the United States Food and Drug Administration due to reported heart attacks and other serious cardiac events potentially associated with GranuFlo.
The process of dialysis is meant to clear toxic waste out of the blood among patients who have failed or failing kidneys. Patients undergoing dialysis are administered bicarbonate to mitigate the acid which builds up inside the blood.
Fresenius Medical Care’s product, GranuFlo, has a certain ingredient which converts to bicarbonate at more dangerous levels than other rival products. This conversion may cause very dangerous levels of bicarbonate in patients.
Fresenius Medical Care’s dialysis product, GranuFlo has been linked to potentially causing alkalosis which is a very serious condition linked to a higher risk of cardiovascular events.
The Food and Drug Administration (FDA) has received numerous complaints from various parties related to errors in dosing alkali which happened during hemodialysis when dialysate concentrates were used containing acetic acid and acetate. If these concentrates are metabolized, they can cause a higher level of bicarbonate in patients going through hemodialysis.
These higher levels of bicarbonate may lead to metabolic alkalosis which may be linked with the following:
A recently conducted study discovered that patients who had bicarbonate levels greater than 28mEq/L before dialysis were almost 5 times as likely to suffer from cardiac arrest.
The Food and Drug Administration (FDA) has enacted a Class 1 recall of Fresenius Medical Care’s product GranuFlo. This is one of the most severe measures that the FDA will take. It means that they believe there is a reasonable probability that continued use of GranuFlo may risk serious injury or even death.
OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B
Fresenius is currently under investigation by the FDA to see whether the company violated federal regulations by not alerting all customers of GranuFlo & NaturaLyte of the health risks. The FDA issued a Class 1 recall of GranuFlo & NaturaLyte from all clinics on June 27, 2012.
If you or a loved one has experienced cardiac arrest, heart attack, stroke following dialysis with GranuFlo or Naturalyte, please contact the Willis Law Firm for a free consultation for a potential GranuFlo dialysis lawsuit. You may be entitled to financial compensation from the makers of GranuFlo in a GranuFlo dialysis lawsuit.