Tuesday, August 28, 2012

August 2012 Granuflo Recall News

The manufacturer of GranuFlo, Fresenius Medical Care North America, treats about one-third of all Americans receiving dialysis.  It also supplies dialysis products and machines to many clinics in addition to their own.  Incorrect prescription of this product has the potential for high serum bicarbonate levels in patients undergoing hemodialysis.  This could lead to metabolic alkalosis, a risk associated with low blood pressure, hypoxemia, hypercapnia, hypokalemia and cardiac arrhythmia.  If these issues are not treated promptly and appropriately, cardiopulmonary arrest, or even death, could result.
Serum Bicarbonate: A measure of the bicarbonate level in the blood based on a venipuncture specimen. The serum carbon dioxide is one of the normally reported values in the electrolytes profile. Lower levels of carbon dioxide indicate an acidosis. The normal level is 20 to 29 mEq/L. Lower than normal levels can indicate diabetic ketoacidosislactic acidosis, alcoholic ketoacidosiskidney diseaserenal failurediarrhoeaAddison's diseaseethylene glycol poisoning or methanol poisoning.
Read more: http://wiki.answers.com/Q/What_is_the_normal_serum_bicarbonate_level#ixzz24rJ3xPwP 
What is metabloic alkalosis? 
Metabolic alkalosis is a metabolic condition in which the pH of tissue is elevated beyond the normal range which is considered  7.35-7.45.
On November 4, 2011, an internal memo from Fresenius Medical Care was sent out to their Medical Directors and Attending Physicians regarding data suggesting GranuFlo could be associated with elevated bicarbonate levels along with an increased risk of cardiopulmonary arrest and sudden cardiac death.  
At the time of this internal memo, these results were only sent to company-owned dialysis treatment centers, not other clinics that operate independently.   In March 2012, Fresenius then communicated the warnings to dialysis clinics not owned or operated by the company.  Because of the information listed above, along with the GranuFlo Recall, dialysis centers are now checking bicarbonate levels and adjusting doses if found necessary.
We are investigating any link between this recall and any possible injuries, call us 404 451 7781.