GranuFlo and NaturaLyte

Drliscol frm p.c. the GRANUFLO / NATURALYTE Granuflo Dry Acid Concentrate and Naturalyte Liquid Acid Concentrate are medical products used during hemodialysis, or the filtering of wastes from the blood of patients with acute andchronic renal (kidney) failure. They are added to the solution patients receive during treatment to replenish nutrients that are lost during the process. Manufacturer: V Fresenius Medical Care | FDA Approval: Approved in 2003 CLASS 1 RECALL In March 2012, the FDA issued a Class 1 recall notice for Granuflo (dry) and Naturalyte (liquid) acid concentrates due to the risk that improper mixtures of the products could contribute to a high serum bicarbonate level in hemodialysis patients and trigger metabolic alkalosis. This concentrate was manufactured and distributed from January 2008 through June 2012. A Class 1 recall is the most serious kind. It involves situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or even death WHAT IS METABOLIC ALKALOSIS? Metabolic Alkalosis occurs when the body has too much of an alkaline substance. It significantly raises the risk of: Cardiopulmonary arrest (heart attack) Cardiac arrhythmia (irregular heart rate) Нурохеmiа (low blood oxygen) Hypokalemia (low potassium levels) Нуpercapnia (increased CO2 in blood) Hypotension (low blood pressure) If untreated, metabolic alkalosis can lead to convulsions, heart failure and coma RENAL WEB AND NEW YORK TIMES INVESTIGATION In the spring of 2012, two news outlets (RenalWEB and the New York Times), reported that Fresenius medical office had issued an internal memo to its dialysis centers in November 2011, warning that failure to properly use GranuFlo "appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest." But Fresenius did not warn other centers using the product until March 2012 - after the FDA has anonymously received a copy of the memo and began an enquiry, the New York Times said THE NUMBERS 398,861 1 in 3 kidney patients in the United States were being treated with some form of dialysis by the end of 2009, according to statistics from the Department of Health and Human Services of the nation's kidney patients undergoing dialysis treatment are treated by Fresenius according to the New York Times 941 DIALYSIS PATIENTS suffered cardiac arrest inside Fresenius clinics in 2010, according to a Nov 11 FMC internal memo published in the NYT To report Granulo / Naturalyte side effects, visit the FDA MedWatch reporting site or call (800) FDA-1088 SOURCES Class I Recall, U.S. Food and Drug Administration | U.S. Department of Health & Human Services "Dialysis Patient Survival is Better at Frenesius Medical Care Clinics Because.. Part l" RenalWEB "Dialysis Company's Failure to Warn of Product Risk Draws Enquiry" New York Times DISLAIMER This information is provided for educational purposes only and is not intended to serve as medical or legal advice. Neither the Driscoll Firm P.C. nor ConsultWebs.com Inc. assumes responsibility for any healthcare decisions or treatment based on the information that is provided herein. Any patient concerned about the side effects of a drug, medical device or medical product should not discountinue or alter use of the drug, device or product in any manner without first consulting with their doctor Drliscol frm p.c. the GRANUFLO / NATURALYTE Granuflo Dry Acid Concentrate and Naturalyte Liquid Acid Concentrate are medical products used during hemodialysis, or the filtering of wastes from the blood of patients with acute andchronic renal (kidney) failure. They are added to the solution patients receive during treatment to replenish nutrients that are lost during the process. Manufacturer: V Fresenius Medical Care | FDA Approval: Approved in 2003 CLASS 1 RECALL In March 2012, the FDA issued a Class 1 recall notice for Granuflo (dry) and Naturalyte (liquid) acid concentrates due to the risk that improper mixtures of the products could contribute to a high serum bicarbonate level in hemodialysis patients and trigger metabolic alkalosis. This concentrate was manufactured and distributed from January 2008 through June 2012. A Class 1 recall is the most serious kind. It involves situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or even death WHAT IS METABOLIC ALKALOSIS? Metabolic Alkalosis occurs when the body has too much of an alkaline substance. It significantly raises the risk of: Cardiopulmonary arrest (heart attack) Cardiac arrhythmia (irregular heart rate) Нурохеmiа (low blood oxygen) Hypokalemia (low potassium levels) Нуpercapnia (increased CO2 in blood) Hypotension (low blood pressure) If untreated, metabolic alkalosis can lead to convulsions, heart failure and coma RENAL WEB AND NEW YORK TIMES INVESTIGATION In the spring of 2012, two news outlets (RenalWEB and the New York Times), reported that Fresenius medical office had issued an internal memo to its dialysis centers in November 2011, warning that failure to properly use GranuFlo "appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest." But Fresenius did not warn other centers using the product until March 2012 - after the FDA has anonymously received a copy of the memo and began an enquiry, the New York Times said THE NUMBERS 398,861 1 in 3 kidney patients in the United States were being treated with some form of dialysis by the end of 2009, according to statistics from the Department of Health and Human Services of the nation's kidney patients undergoing dialysis treatment are treated by Fresenius according to the New York Times 941 DIALYSIS PATIENTS suffered cardiac arrest inside Fresenius clinics in 2010, according to a Nov 11 FMC internal memo published in the NYT To report Granulo / Naturalyte side effects, visit the FDA MedWatch reporting site or call (800) FDA-1088 SOURCES Class I Recall, U.S. Food and Drug Administration | U.S. Department of Health & Human Services "Dialysis Patient Survival is Better at Frenesius Medical Care Clinics Because.. Part l" RenalWEB "Dialysis Company's Failure to Warn of Product Risk Draws Enquiry" New York Times DISLAIMER This information is provided for educational purposes only and is not intended to serve as medical or legal advice. Neither the Driscoll Firm P.C. nor ConsultWebs.com Inc. assumes responsibility for any healthcare decisions or treatment based on the information that is provided herein. Any patient concerned about the side effects of a drug, medical device or medical product should not discountinue or alter use of the drug, device or product in any manner without first consulting with their doctor