PLASMACELL XI DISPOSABLE SET WITH SPIKESMART

Description of Event or Problem

ON (B)(6) 2026, (B)(6) RECEIVED IN-PERSON NOTIFICATION OF THE DEATH A DONOR, HEREINAFTER (B)(6). THE DONOR DEATH WAS REPORTED BY A RELATIVE OF (B)(6). THE RELATIVE PROVIDED THE FOLLOWING ADDITIONAL DETAILS: (B)(6) HAD DONATED PLASMA ON (B)(6) 2026 AND BEGAN EXPERIENCING CHEST PAIN WHILE CHANGING A FLAT AUTOMOBILE TIRE AFTER LEAVING THE PLASMA CENTER. (B)(6) WAS TRANSPORTED BY AMBULANCE TO A LOCAL HOSPITAL, WHERE THE RELATIVE WAS INFORMED THAT (B)(6) HAD EXPERIENCED A HEART ATTACK. THE RELATIVE REPORTED THAT (B)(6) DIED AT THE HOSPITAL ON (B)(6) 2026 AT 1659. THE RELATIVE ALSO STATED THAT (B)(6) HAD A PREEXISTING UNKNOWN CARDIAC CONDITION. A PUBLICLY AVAILABLE OBITUARY CORROBORATES THE REPORTED DATE OF DEATH AND A REVIEW OF DONOR RECORDS CONFIRMS THAT (B)(6) LAST DONATED ON (B)(6) 2026. THE (B)(6) PHYSICIAN CONTACTED THE MEDICAL EXAMINER'S OFFICE ON (B)(6) 2026 AND WAS INFORMED THAT DECEDENT RECORD INDICATED THAT MEDICAL EXAMINER EVALUATION WAS DECLINED, THAT NO AUTOPSY WAS PERFORMED, THAT NO DATE NOR TIME OF DEATH COULD BE PROVIDED AND THAT NO RECORDS WERE AVAILABLE FOR RELEASE. NO HOSPITAL MEDICAL RECORDS HAVE BEEN PROVIDED TO CONFIRM THE REPORTED CAUSE OF DEATH OR CONTRIBUTING FACTORS. THE 45-YEAR-OLD MALE DONOR HAD A TOTAL OF 18 DONATIONS BEGINNING ON (B)(6) 2026. HIS LAST DONATION BEGAN AT 1106 ON (B)(6) 2026, WITH ALL PARAMETERS FOR PLASMAPHERESIS FOUND ACCEPTABLE (WT 282LBS, BP 142/89 MMHG, PULSE 92 BPM, TEMP. 98.1F, HCT 52% AND TP 7.4 G/DL). THE ELECTRONIC DONOR QUESTIONNAIRE ADMINISTERED ON THE DAY OF DONATION SHOWED NO NEW ABERRANT RESPONSES. THE DONATION PROCEEDED WITHOUT EVENT WITH 971ML OF PLASMA COLLECTED FROM HIS RIGHT ARM AND WITH PROCEDURAL SALINE GIVEN. THE DONATION CONCLUDED AT 1226. THE DONOR WAS RELEASED ASYMPTOMATIC FOLLOWING COMPLETION OF THE PROCEDURE. AFTER THE CENTER WAS MADE AWARE OF THE DONOR'S DEATH, THE EMPLOYEE WHO PERFORMED THE PLASMAPHERESIS PROCEDURE WAS QUESTIONED AND REPORTED NO DIFFICULTIES WITH THE DONATION PROCESS. FOLLOW-UP INFORMATION INDICATED THAT NO ADDITIONAL UNDERLYING OR NEWLY IDENTIFIED MEDICAL CONDITIONS, MEDICATION CHANGES, OR PRIOR ADVERSE DONATION REACTIONS WERE RELEASED. THE DONOR REPORTEDLY DID NOT EXPERIENCE SYMPTOMS DURING THE DONATION AND WAS RELEASED ASYMPTOMATIC. REVIEW OF THE DONOR'S RECORDS FOR THE PRECEDING TWO YEARS DEMONSTRATES THE FOLLOWING: THE DONOR'S MOST RECENT PHYSICAL EXAM WAS PERFORMED ON (B)(6) 2026 WITH THE FOLLOWING ABERRANT FINDINGS NOTED ON THE QUESTIONNAIRE: A HISTORY OF CHOLECYSTECTOMY IN 2019 AND DONOR ENTRY ERRORS, WITH APPROPRIATE ANSWERS CONFIRMED PER DONATION CENTER SOP. DONOR INDICATED NO MEDICATIONS FROM THE MEDICATION DEFERRAL LIST TAKEN IN THE TIMEFRAMES LISTED. ONLY TATTOOS/PIERCINGS IN PLACE GREATER THAN 12 MONTHS WERE DOCUMENTED AS FINDINGS ON PHYSICAL EXAM. THE DONOR NOTED USE OF THE FOLLOWING ACCEPTABLE MEDICATIONS: NONE. THE DONOR HISTORY RECORD WAS REVIEWED, AND THE DONOR DID HAVE INITIAL DIASTOLIC BLOOD PRESSURE MEASUREMENTS ABOVE THE ACCEPTABLE RANGE SIX TIMES FROM (B)(6) OF 2026, WITH THEIR DIASTOLIC BLOOD PRESSURE HAVING AN ACCEPTABLE SUBSEQUENT VALUE ON RE-TAKE PER SOP ON FOUR OF THESE OCCASIONS AND WITH A SINGLE DAY TEMPORARY DEFERRAL APPLIED IN THE OTHER TWO INSTANCE. THE DONOR'S REACTION HISTORY WAS REVIEWED, AND NO PRIOR DONOR REACTIONS ARE DOCUMENTED. THE DONOR HAD A VENOUS BLOOD SAMPLE COLLECTED AND SERUM PROTEIN ELECTROPHORESIS PERFORMED ON (B)(6) 2026 WITH ALL PROTEIN FRACTIONS WITHIN ACCEPTABLE RANGES AND WITH THE SCAN TRACING DEMONSTRATING AN APPROPRIATE SERUM PROTEIN PATTERN. ON (B)(6) 2026, THE DONATION CENTER STAFF REMOVED THE AURORA XI INSTRUMENT FROM SERVICE THAT WAS USED IN THE DONOR'S LAST PLASMA COLLECTION ON (B)(6) 2026. THE PREVENTATIVE MAINTENANCE TPDS WAS PERFORMED ON 5 MAY 2026 AND FOUND THE INSTRUMENT WAS WORKING AS INTENDED. THE FOLLOWING INSTRUMENT MAINTENANCE DOCUMENTS WERE REVIEWED FROM 25 APRIL 2024 TO 25 APRIL 2026: LAST ANNUAL AND REQUIRED PMS, PLASMAPHERESIS INSTRUMENT TROUBLESHOOTING LOGS, THE PREVENTATIVE AND CORRECTIVE MAINTENANCE RECORDS AND THE INSTRUMENT WEIGHT SCALE VERIFICATIONS. THE DEVICE WAS WORKING AS INTENDED ON THE DAY OF THE EVENT. NO KIT SAMPLE IS AVAILABLE FOR EVALUATION. THE BATCH RECORDS WERE REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOTS HAVE PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. DEVICE LOG FILE ANALYSIS DEMONSTRATED THAT THE PROCEDURE WAS COMPLETED WITHIN EXPECTED OPERATIONAL PARAMETERS, WITH FULL COLLECTION AND REINFUSION VOLUMES ACHIEVED AND ANTICOAGULANT DELIVERY PROPORTIONAL TO THE VOLUME PROCESSED. DURING THE PROCEDURE, A SINGLE REDNESS ALERT OCCURRED EARLY IN THE COLLECTION AND RESOLVED WITH AUTOMATED SYSTEM ADJUSTMENTS, FOLLOWED BY A LOW ANTICOAGULANT ALERT NEAR COMPLETION. REVIEW OF ASSOCIATED PRESSURE TRENDS, HEMOGLOBIN DETECTOR DATA, AND SYSTEM PARAMETERS DEMONSTRATED PATTERNS CONSISTENT WITH EXPECTED SYSTEM OPERATION. NO SUSTAINED ABNORMALITIES OR ADDITIONAL ALERTS WERE IDENTIFIED. POST-EVENT TECHNICAL EVALUATION, INCLUDING TPDS AND DATA LOG REVIEW, CONFIRMED THE DEVICE WAS FUNCTIONING AS INTENDED, AND MAINTENANCE RECORDS SUPPORT THAT THE DEVICE WAS OPERATING WITHIN SPECIFICATIONS AT THE TIME OF USE. OVERALL LOGFILE REVIEW DID NOT IDENTIFY EVIDENCE OF DEVICE MALFUNCTION. WHILE THE AVAILABLE INFORMATION DOES NOT INDICATE A DEVICE MALFUNCTION OR PROCEDURAL COMPLICATION, THE MEDICAL ASSESSMENT IS LIMITED BY THE ABSENCE OF CONFIRMATORY MEDICAL RECORDS, AUTOPSY FINDINGS, AND OFFICIAL CAUSE OF DEATH DOCUMENTATION. BASED ON THE REPORTED FATAL OUTCOME, A SERIOUS ADVERSE EVENT OCCURRED. HOWEVER, DUE TO THE LIMITATIONS OF THE AVAILABLE INFORMATION, A DEFINITIVE DETERMINATION REGARDING WHETHER THE COMPLAINT DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT CANNOT BE MADE. FRESENIUS KABI IS REPORTING THIS EVENT CONSERVATIVELY.