BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLASMACELL XI DISPOSABLE SET WITH SPIKESMART

    MDR report key: 20441362 · Received October 14, 2024

    Report

    Report Number
    3004548776-2024-00409
    Event Type
    Death
    Date Received
    October 14, 2024
    Date of Event
    September 11, 2024
    Report Date
    May 27, 2025
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    UDI-DI
    00810020441116
    PMA / PMN Number
    BK160028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DONOR WAS A 46-YEAR-OLD MALE THAT HAS 143 DONATIONS AVAILABLE FOR REVIEW IN THE CURRENT BECS SYSTEM DATING BACK TO (B)(6) 2023. THE DONOR HAS ALSO DONATED AT THIS CENTER PRIOR TO (B)(6) 2023 WITH DONATION DATA IN A SEPARATE BECS SYSTEM DATA BASED. REVIEW OF THE DONORS' DONATIONS BACK TO (B)(6) 2023 INCLUDING THE DONOR'S MOST RECENT ANNUAL DONOR ELIGIBILITY ASSESSMENT FROM (B)(6) 2023 REVEALED NO DONOR REPORTED MEDICAL CONDITIONS, MEDICATIONS, OR ALLERGIES. THE PHYSICAL EXAM FROM THIS DATE WAS UNREMARKABLE. DURING THIS TIME FRAME NO DONOR ADVERSE EVENTS WERE DOCUMENTED AND THE DONOR WAS DEFERRED ONE TIME ON (B)(6) 2023 FOR A LESS THAN 200 ML RBC LOSS. NO DEFERRAL TRENDS WERE NOTED ALTHOUGH THE DONOR DID REQUIRE A REPEAT VENIPUNCTURE SEVERAL TIMES DURING THIS DONATION TIME FRAME. THE MOST RECENT SPE WAS COLLECTED ON (B)(6) 2024 AND WAS ACCEPTABLE. THE DONATION BEGAN AT 10:03 AM FOLLOWING A SUCCESSFUL VENIPUNCTURE IN THE LEFT ARM. THE TOTAL COLLECTION VOLUME WAS 897ML AND THE PLASMA COLLECTION VOLUME WAS 801ML. THE DONOR RECEIVED 500ML OF PROCEDURAL SALINE. NO APHERESIS COMPLICATIONS OR DONOR ADVERSE EVENTS WERE NOTED DURING OR AFTER THE DONATION. CENTER MANAGEMENT REVIEWED THE VIDEO FOOTAGE FROM THE DONATION AND DID NOT OBSERVE ANYTHING OUT OF THE ORDINARY. THE DONOR LEFT THE CENTER IN STABLE CONDITION. THE DONOR CENTER LEARNED OF THE DONOR'S DEATH ON (B)(6) 2024 WHEN AN ACQUAINTANCE OF THE DONOR INFORMED THE STAFF THAT THE DONOR HAD DIED. THIS INDIVIDUAL DID NOT HAVE ANY OTHER INFORMATION REGARDING THE CIRCUMSTANCES OF THE DONOR'S DEATH. DIRECTOR, PLASMA MEDICAL DEPARTMENT CONTACTED THE (B)(6) CORONER'S OFFICE AND SPOKE WITH DEPUTY CORONER. DEPUTY CORONER CONFIRMED THE DATE AND TIME OF DEATH AND THAT THEIR OFFICE INVESTIGATED THE DEATH. ON THE EVENING OF (B)(6) 2024, THE DONOR WAS ALONE AT HIS RESIDENCE WHEN HE BEGAN TO FEEL SHORT OF BREATH AND CALLED 911. WHEN EMS ARRIVED, THE DONOR COLLAPSED, AND THEY TRANSPORTED HIM TO (B)(6) MEDICAL CENTER WHERE RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL, AND HE WAS PRONOUNCED DEAD AT 8:43 PM ON (B)(6) 2024. THE INVESTIGATION WAS REFERRED TO THE (B)(6) BUREAU OF INVESTIGATION (B)(6) DIVISION OF FORENSIC SCIENCES FOR AUTOPSY AND TOXICOLOGY. THERE IS NO PRELIMINARY CAUSE AND / OR MANNER OF DEATH AND IT MAY TAKE UP TO 6 MONTHS TO RECEIVE THE FINAL AUTOPSY AND TOXICOLOGY REPORTS. DEPUTY CORONER SHARED THAT THE DONOR'S FAMILY REPORTED THAT THE DONOR HAD A DIAGNOSIS OF DIABETES AND A HISTORY OF SUBSTANCE ABUSE (ALCOHOL, CRACK COCAINE, AND METHAMPHETAMINE). EMS PERSONNEL DID NOT REPORT ANY DRUG PARAPHERNALIA AT THE SCENE. ALTHOUGH IT SOUNDS LIKE THE DONOR MAY HAVE EXPERIENCED SUDDEN CARDIAC ARREST, THE UNDERLYING CAUSE IS NOT CURRENTLY KNOWN. WE DON'T EXPECT ANY ADDITIONAL INFORMATION ON THE CAUSE UNTIL THE AUTOPSY IS COMPLETE AND THE FINAL REPORT GENERATED. AS NOTED ABOVE, THIS COULD TAKE SEVERAL MONTHS. FRESENIUS KABI IS CONSERVATIVELY REPORTING THIS INCIDENT AS THE CAUSE OF DEATH IS UNKNOWN. AT THIS TIME, THERE IS NO EVIDENCE THAT THE PLASMA DONATION CAUSED OR CONTRIBUTED TO THE REPORTED DEATH.

    Description of Event or Problem · 0

    NO KIT SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. THEREFORE, THE CUSTOMER REPORTED COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE IDENTIFIED. THE FOLLOWING CURRENT CONTROLS ARE IN PLACE TO ASSURE INTEGRITY OF THE KIT 1) IN PROCESS SAMPLING QUALITY INSPECTION AND 2) POST STERILIZATION SAMPLING FINAL INSPECTION. ADDITIONALLY, THE BATCH RECORD FOR KIT BATCH FA24E29067 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. LOG FILES WERE OBTAINED FROM THE AURORA XI DEVICE FOR REVIEW. THE PROCEDURE COLLECTED 897/896 ML AND INFUSED 500/500 ML OF SALINE IN 8 CYCLES OVER 55.3 MINUTES, WHICH IS SLIGHTLY LONGER THAN NORMAL FOR AURORA XI. THE PROCEDURE EXPERIENCED A NUMBER OF OCCLUSIONS AND REDUCED FLOW RATES (AS LOW AS 50 ML/MIN DRAW AND 95 ML/MIN RETURN). IN CYCLES 1, 2, AND 3, A TOTAL OF 4 AUTO-RECOVERING OCCLUSIONS OCCURRED, WITH TWO OCCURRING IN CYCLE 3, CULMINATING IN ALERT 3508 IN CYCLE 4. AFTER THE ALERT WAS CLEARED, TWO MORE AUTO RECOVERING OCCLUSIONS OCCURRED. CYCLES 5 AND 8 HAD AN AUTO-RECOVERING AIR PURGE ALERT 3100; AIR WAS PURGED INTO THE RESERVOIR AS INTENDED. CYCLE 5 REQUIRED A SECOND AIR PURGE, AND IN BOTH CYCLE 5 AND 8 THE PROCEDURE WAS RESUMED UPON CLEARING THE ALERT. READINGS OF THE PLASMA SCALE, RESERVOIR SCALE, HB DETECTOR, P2, AND CUFF PRESSURE WERE TYPICAL. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE FSE (FIELD SERVICE ENGINEER) STATED THE TPDS (TEST PROCEDURE DATA SHEET) WAS COMPLETED. THE FSE STATED THAT THE DEVICE PASSED ALL TESTING AFTER THE PART WAS REPLACED. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. A DEVICE HISTORY REVIEW OF THE DEVICE SERIAL NUMBER (B)(6) WAS CONDUCTED IN ORDER TO IDENTIFY POTENTIAL RELATED MANUFACTURING NON-CONFORMANCES. THE REVIEW YIELDED NO NON-CONFORMANCES RELATED TO THIS ISSUE. A REVIEW OF THE SERVICE RECORDS FOR THIS DEVICE, SERIAL NUMBER (B)(6) FOUND NO SAME/SIMILAR COMPLAINTS RELATED TO THIS ONE. A SEARCH OF CAPAS FOUND NO RELATED ISSUES. A MONTHLY TREND IS PERFORMED TO DETERMINE THE NEED TO INITIATE AN INVESTIGATION DUE TO AN INCREASE IN COMPLAINTS FOR THE CORRESPONDING DEFECT CATEGORY OR TO DETERMINE IF CORRECTIVE ACTIONS ARE NEEDED. NO ADVERSE TREND WAS OBSERVED IN THE LAST PRODUCT REVIEW MEETING PERFORMED BEFORE THIS COMPLAINT WAS RECEIVED. FRESENIUS KABI HAS DETERMINED THAT THE DEVICE DID NOT CONTRIBUTE TO THE DONOR'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872643 PLASMACELL XI DISPOSABLE SET WITH SPIKESMART FOR COLLECTION OF PLASMA BY MEMBRANE FILTRATION. FOR USE WITH THE AURORA XI INST GKT FENWAL INTERNATIONAL INC. 6R2600P FA24E29067 00810020441116

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death