FDA Issues Recall of Naturalyte and Granuflo After more than 900 cases of Cardiac Arrest at Fresenius Dialysis Clinics
Federal regulators are issuing a Class I recall for Fresenius Medical Care’s NaturaLyte and GranuFlo dialysis products. The two products were both manufactured and also distributed between January 2008 until June 2012. Naturalye and Granuflow are used to treat acute and chronic renal failure through hemodialysis. The concentrates are used with a ‘three-stream hemodialysis machine.’
Dosage errors involving GranuFlo and NaturaLyte have been implicated in more than 900 cases of cardiac arrest at Fresenius-owned dialysis clinics.
Fresenius Medical Care North America is warning medical professionals to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) that Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate contain. Inappropriate (too high) of a prescription of these products can and has lead to a high serum bicarbonate level in patients undergoing hemodialysis. A high serum bicarbonate level may contribute to metabolic alkalosis (MA). MA is a significant risk factor for dangerous conditions such as low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia. If any of these problems are not appropriately treated, they may culminate in cardiopulmonary arrest and death.
Class 1 recalls are the most stringent type of recall. They involve situations in which there is a “reasonable probability that use of these products will cause serious adverse health consequences or death.”
Source – FDA