Tuesday, August 28, 2012
August 2012 Granuflo Recall News
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 ketoacidosis, lactic acidosis, alcoholic ketoacidosis, kidney disease, renal failure, diarrhoea, Addison's disease, ethylene glycol poisoning or methanol poisoning.Read more: http://wiki.answers.com/Q/What_is_the_normal_serum_bicarbonate_level#ixzz24rJ3xPwP
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 , 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.