HEALTHCARE PROFESSIONAL REPORTED OUT OF RANGE HIGH READINGS WITH HEMOCHRON SIGNAURE ELITE AND ACT PLUS SYSTEM. A (B)(6) MALE PATIENT WAS RECEIVING IV HEPARIN WHILE ON CARDIVASCULAR BYPASS DURING AN AORTIC VALVE REPAIR PROCEDURE. THE TARGET ACT WAS 440-480 SECONDS. THE HEMOCHRON SIGNATURE ELITE AND ACT PLUS SYSTEM REPORTED TWO CONSECUTIVE ACT RESULTS THAT WERE OUT OF RANGE HIGH (>1005 SECONDS). TIMES OF ADMINISRATION AND DOSAGE OF HEPARIN WERE NOT SPECIFIED. THE CASE CONTINUED AND A SUBSEQUENT ACT MEASURED WITH THE SME HEMOCHRON SIGNAURE ELITE AND ACT PLUS SYSTEM WAS 379 SECONDS, WHICH WAS BELOW THE TARGET ACT RANGE. BOTH ELECTRONIC AND LIQUID QUALITY CONTROLS PASSED. THE PROCEDURE WAS AS FOCOMPLETED SUCESSFULLY AND NO PATIENT INJURY OR ADVERSE EVENTS WERE REPORTED.
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Patient 1
(B)(4). THE SERIAL NUMBER OF THE HEMOCHRON SIGNATURE ELITE INSTRUMENT USED DURING THIS PROCEDURE IS (B)(4). ASSESSMENT OF (B)(4) CONCLUDED THAT IT WAS UNRELATED TO THE COMPLAINT. NO OTHER NCRS OR OTHER ANOMALIES RELATED TO THE COMPLAINT WERE IDENTIFIED. NO CURRENT LOT OR PRODUCT TRENDS. NO CAPA. DESPITE MULTIPLE REQUESTS BY ITC FOR THE HEPARIN DOSES AND TIMING OF DRUG ADMINISTRATION, THE END USER HAS REFUSED TO PROVIDE THE REQUESTED INFORMATION. ITC WILL CONTINUE FOLLOWING THIS COMPLAINT AND WILL REPORT A FOLLOW-UP MDR IF THIS INFORMATION BECOMES AVAILABLE. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.