Description of Event or Problem · 0
A 54-YEAR-OLD FEMALE DONOR EXPERIENCED A FATAL MEDICAL EVENT FOLLOWING A ROUTINE PLASMA DONATION PERFORMED ON (B)(6) 2026. THE DONOR COMPLETED A TOTAL OF THREE PLASMA DONATIONS AT THE DONOR CENTER ON (B)(6) 2026. THE DONOR MET ALL DOCUMENTED DONOR ELIGIBILITY CRITERIA FOR EACH DONATION, INCLUDING THE FINAL DONATION ON (B)(6) 2026. THE DONOR PASSED AWAY ON (B)(6) 2026. NO AUTOPSY REPORT, HOSPITAL MEDICAL RECORDS, LABORATORY RESULTS, OR DIAGNOSTIC IMAGING ARE AVAILABLE FOR REVIEW. THIRD PARTY INFORMATION FROM THE DONOR'S RELATIVES INDICATE THE DONOR'S DEATH WAS DUE TO COMPLICATIONS FROM ACUTE MYOCARDIAL INFARCTION POST CORONARY ARTERY STENTING. AT THE TIME OF DONOR SCREENING PRIOR TO THE FIRST DONATION ON (B)(6) 2026, THE DONOR DISCLOSED A MEDICAL HISTORY OF ASTHMA AND PREMENSTRUAL DYSPHORIC DISORDER AND REPORTED USE OF FLUTICASONE INHALER, IPRATROPIUM BROMIDE (ATROVENT), SALBUTAMOL, AND SERTRALINE. DURING DONOR HEALTH QUESTIONNAIRE SCREENING ON (B)(6) 2026.THE DONOR ANSWERED AFFIRMATIVELY TO A HISTORY OF HEART OR LUNG PROBLEMS, DISCLOSING ASTHMA ONLY. FOLLOWING THE DONOR'S DEATH, THE DONOR'S SON REPORTED ON (B)(6) 2026, THAT THE DONOR HAD A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), WHICH WOULD RENDER THE DONOR INELIGIBLE. IT IS UNKNOWN WHEN THIS DIAGNOSIS WAS ESTABLISHED, WHETHER IT HAD BEEN PREVIOUSLY DISCLOSED TO THE DONOR CENTER, OR WHETHER THE DONOR WAS SYMPTOMATIC AT THE TIME OF DONATION. PLASMA COLLECTION VOLUMES WERE CONSISTENT ACROSS DONATIONS, WITH 881 ML COLLECTED ON (B)(6) 2026, 881 ML ON (B)(6) 2026, AND 880 ML ON (B)(6) 2026. DONOR HEIGHT WAS RECORDED AS 155 CM, WITH WEIGHTS RANGING FROM 177 TO 179 POUNDS AND HEMATOCRIT VALUES OF 50% AT EACH DONATION. DURING THE FINAL DONATION, A TOTAL BLOOD VOLUME OF APPROXIMATELY 3577 ML WAS PROCESSED, AND 500 ML OF SALINE WAS REINFUSED. NO ADDITIONAL BLOOD SAMPLES OR LABORATORY TESTING WERE PERFORMED AT THE TIME OF THE FINAL DONATION. THE FINAL DONATION WAS PERFORMED USING THE AURORA PLASMAPHERESIS SYSTEM. SYSTEM ALERTS OCCURRED DURING THE PROCEDURE, INCLUDING AN "AIR IN LINE" ALERT REQUIRING MANUAL PURGE, A "HIGH RETURN PRESSURE" ALERT DURING THE FIRST RETURN CYCLE THAT WAS RESOLVED WITH TROUBLESHOOTING, AND A "NO BLOOD FLOW" ALERT. FOLLOWING THESE INTERVENTIONS, THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF DONOR-EXPERIENCED SYMPTOMS, ACUTE REACTIONS, OR HEMODYNAMIC INSTABILITY DURING OR IMMEDIATELY FOLLOWING THE DONATION. THE AURORA DEVICE, AURORA DISPOSABLE COLLECTION SET AND THE COLLECTION CONTAINER USED DURING THE DONOR'S FINAL DONATION ARE ALL MANUFACTURED BY FRESENIUS KABI. THE NEEDLE AND ANTICOAGULANT USED DURING THE DONOR'S FINAL DONATION WERE MANUFACTURED ELSEWHERE. A FRESENIUS KABI FIELD SERVICE ENGINEER PERFORMED A TEST PROCEDURE DATA SHEET (TPDS) ON THE AURORA DEVICE INVOLVED WITH THIS EVENT. THE TPDS WAS COMPLETED WITHOUT ISSUES AND THE DEVICE WAS PERFORMING TO SPECIFICATION. BASED ON THE AURORA DEVICE LOG FILES, THE DONOR'S FINAL PROCEDURE ON (B)(6) 2026 COLLECTED 880/880 ML AND INFUSED 500 ML SALINE IN 78.7 MINUTES OF PROCESSING TIME (82.0 MINUTES FROM NEEDLE IN TO NEEDLE OUT). DURING THE FIRST DRAW, THE DRAW RATE WAS REDUCED AUTOMATICALLY FROM 120 TO 110 ML/MIN. DURING THE FIRST RETURN, ALERT 3101 FOR AIR DETECTED OCCURRED, IMMEDIATELY FOLLOWED BY ALERT 3602 FOR A RETURN OCCLUSION. NO DRAW/RETURN RATE ADJUSTMENTS WERE MADE, AND THE PROCEDURE WAS RESUMED. THE PROCEDURE REMAINED UNEVENTFUL, UNTIL 57 MINUTES INTO THE PROCEDURE, WHEN THE RETURN RATE WAS DECREASED FROM 150 TO 100 ML/MIN. AT 62 MINUTES INTO THE PROCEDURE, ALERT 3508 FOR DRAW OCCLUSION OCCURRED; UPON RESUMPTION, THE DRAW RATE WAS REDUCED FROM 110 TO 100 ML/MIN. THE PROCEDURE CONTINUED TO COMPLETION. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE OBSERVED ALERTS AND OCCLUSIONS ARE NOT RELATED TO DEVICE PERFORMANCE ISSUES. SYSTEM BEHAVIOR REMAINED WITHIN NORMAL EXPECTED FUNCTION. COMPLAINT AND CAPA QUERIES WERE PERFORMED BY FRESENIUS KABI (B)(6). THIS IS THE FIRST COMPLAINT RECEIVED FOR AURORA DEVICE SERIAL NUMBER (B)(6). OF THE (B)(6) COMPLAINTS RECEIVED FOR THE DISPOSABLE SET BATCH FA25K06038 IN THE PAST 36 MONTHS, THIS IS THE SECOND COMPLAINT RELATED TO AN ADVERSE EVENT. NONE OF THE CAPA EVENTS OPENED FOR THE DEVICE OR DISPOSABLE KIT IN THE PAST 36 MONTHS WERE RELATED TO AN ADVERSE EVENT. ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION WAS ADMINISTERED AT A REPORTED ANTICOAGULANT-TO-BLOOD RATIO OF 6%. NO DEVIATIONS FROM PROGRAMMED ANTICOAGULANT DELIVERY WERE REPORTED. NO ACUTE PULMONARY OR SYSTEMIC SYMPTOMS WERE REPORTED DURING OR IMMEDIATELY AFTER THE DONATION. ALTHOUGH THE DONOR WAS PROPERLY SCREENED AND DOCUMENTED AS MEETING ELIGIBILITY CRITERIA AT THE TIME OF DONATION, SUBSEQUENTLY OBTAINED CLINICAL INFORMATION INDICATES THAT THE DONOR SHOULD NOT HAVE BEEN CONSIDERED ELIGIBLE FOR PLASMA DONATION. BASED ON THE AVAILABLE INFORMATION, A CAUSAL RELATIONSHIP BETWEEN THE DONATION PROCEDURE, ANTICOAGULANT ADMINISTRATION, OR THE FRESENIUS KABI-MANUFACTURED DEVICE COMPONENTS AND THE REPORTED FATAL OUTCOME IS CONSIDERED UNLIKELY. HOWEVER, BASED ON THE LACK OF MEDICAL RECORDS, THIS EVENT IS BEING REPORTED CONSERVATIVELY.