SPECTRA OPTIA APHERESIS SYSTEM

Description of Event or Problem

AN AUTOLOGOUS CELLULAR THERAPY (CTP) COLLECTION WAS PERFORMED ON A (B)(6) Y/O MALE, DIAGNOSED WITH MULTIPLE MYELOMA. THE CTP COLLECTION WAS PERFORMED PER PROTOCOL WITHOUT ANY ISSUES THROUGHOUT THE PROCEDURE, EXCEPT FOR A FEW OCCLUSION ALARMS TOWARDS THE LAST HOUR OF THE PROCEDURE WHICH WERE CENTRAL VENOUS CATHETER RELATED. THE PT PERIPHERAL CD 34 COUNT OF 90 AND A TOTAL OF 16.182 LITERS OF WHOLE BLOOD WAS PROCESSED VIA A TRIPLE LUMEN TRIFUSION CENTRAL VENOUS CATHETER. ACDA-A RATIO USED THROUGHOUT THE PROCEDURE WAS 12:1. AT THE END OF THE PROCEDURE THE CTP LABELING WAS VERIFIED FOR ACCURACY AND VISUAL INSPECTION OF THE CTP WAS PERFORMED AND AUTHENTICATED BY TWO RNS. NO VISUAL ABNORMALITIES OF THE CTP WERE NOTED PRIOR TO DISTRIBUTION TO THE PROCESSING FACILITY. THE PROCESSING FACILITY PERSONNEL WHO ACCEPTED THE CTP ALSO CONFIRMED THE VISUAL INSPECTION OF THE CTP SHOWED NO ABNORMALITIES AT THE TIME OF DISTRIBUTION. AT APPROX 1400, AS STATED BY THE PROCESSING FACILITY PERSONNEL, THE MD WAS NOTIFIED AND HE VISUALLY ASSESSED THE CTP. AFTER CLOSE INSPECTION OF THE CTP, THE CTP WAS DEEMED UNUSABLE.