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warnings and cautions
5 WARNINGS AND PRECAUTIONS Verify that the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure product quality and donor safety. Do not reuse. Discard unused or partially used solution bags. Do not infuse Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A directly to the patients. Do not use the solution if the container is damaged, leaking, or if there is any visible sign of deterioration. Verify that the Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A has been securely attached to the anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure product quality and donor safety. Do not infuse Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A directly to the patients. ( 5 )
6 ADVERSE REACTIONS The following potential adverse events are associated with the use of Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A: embolism, toxic reaction, infection, hypervolemia, and tissue damage. Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease. Report suspected adverse reactions to Terumo BCT, Inc. or the FDA. The following potential adverse reactions are safety-related harms associated with the use of Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A: embolism, toxic reaction, infection, hypervolemia, and tissue damage. Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .