BEUDAMED
    FDA Adverse Event Death Summary report: N

    AURORA PLASMAPHERESIS SYSTEM

    MDR report key: 12712258 · Received October 28, 2021

    Report

    Report Number
    3004548776-2021-00141
    Event Type
    Death
    Date Received
    October 28, 2021
    Date of Event
    September 27, 2021
    Report Date
    September 28, 2021
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    PMA / PMN Number
    BK110072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INITIAL MDR INFORMATION: DONOR WAS A 40-YEAR-OLD MALE, 6' TALL AND 196LBS. TOTAL # OF DONATIONS WERE 95, BEGINNING IN 2018. PER CUSTOMER, APPROXIMATELY ONE HOUR AFTER COMPLETING A DONATION AT THE CENTER ON (B)(6) 2021, THE DONOR WAS FOUND IN HIS CAR IN THE PARKING LOT OF THE DONOR CENTER UNCONSCIOUS AND PULSELESS. RESUSCITATION ATTEMPTS WERE MADE BY BOTH THE MEDICAL CENTER STAFF AND THE LOS ANGELES FIRE DEPARTMENT PARAMEDICS BUT WERE UNSUCCESSFUL. THE DONOR WAS PRONOUNCED DECEASED AT 3:19 PM. THE PRELIMINARY IMPRESSION FROM THE MEDICAL EXAMINER-CORONER'S OFFICE BASED ON THE INVESTIGATION THUS FAR, IS THAT THIS MAY REPRESENT AN ACCIDENTAL DRUG OVERDOSE. AT THE TIME OF THIS REPORT, THE OFFICIAL AUTOPSY RESULTS AND THE TOXICOLOGY REPORT HAVE NOT BEEN MADE AVAILABLE TO FRESENIUS KABI. IF RECEIVED, THIS CONCLUSION WILL BE RE-ASSESSED. DETAILED REVIEW OF THE DONATION RECORDS DATING BACK TO 03/19/2021 REVEALED THAT THE DONOR'S DONATIONS WERE WELL TOLERATED. THE DONOR HAD NO DOCUMENTED ADVERSE EVENTS DURING HIS ENTIRE DONATION HISTORY. NO DEFERRAL TRENDS WERE NOTED. IN GENERAL, IT APPEARS THAT THE DONOR TOLERATED THE PLASMAPHERESIS PROCEDURE WELL. THE DEVICE WAS EVALUATED, AND NO DEVICE MALFUNCTIONS WERE OBSERVED. BATCH REVIEWS WERE WITHOUT EXCEPTION. FRESENIUS KABI HAS NOT FOUND ANY EVIDENCE SUGGESTING THE AURORA PLASMAPHERESIS SYSTEM HAD ANY CAUSALITY WITH THE DONOR FATALITY. HOWEVER, AT THIS TIME, FRESENIUS KABI IS CHOOSING TO REPORT CONSERVATIVELY AS THE OFFICIAL AUTOPSY RESULTS AND THE TOXICOLOGY REPORT HAVE NOT BEEN MADE AVAILABLE TO FRESENIUS KABI. FOLLOW-UP MDR INFORMATION: NO AURORA KIT SAMPLE OR PICTURE WERE MADE AVAILABLE FOR ANALYSIS. NO CONTIBUTING CAUSE CAN BE IDENTIFIED, AS NO DEFECTS IN MATERIAL OR BATCH WERE FOUND. A MONTHLY TREND IS PERFORMED TO DETERMINE THE NEED TO INITIATE AN INVESTIGATION DUE TO AN INCREASE IN COMPLAINTS OR TO DETERMINE IF CORRECTIVE ACTIONS ARE NEEDED. NO TREND WAS OBSERVED FOR THIS DEFECT CATEGORY. THE AURORA KIT BATCH RECORD FA21F30017 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. THE POOLING BOTTLE BATCH RECORD FA21G05108 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. THE CUSTOMER REPORTED THAT SODIUM CITRATE SOLUTION PRODUCT LOT 21JG04018 WAS INVOLVED IN THE REPORTED EVENT WHICH RESULTED IN A DONOR FATALITY; HOWEVER, THERE IS NO ALLEGATION OF PRODUCT DEFICIENCY. THERE WERE NO SAMPLES OR PICTURES PROVIDED BY THE CUSTOMER FOR EVALUATION. THE REVIEW OF THE BATCH PRODUCTION RECORD AND RETAIN SAMPLES WAS PERFORMED WHERE NO FAILURES WERE OBSERVED; THEREFORE, THE MOST PROBABLE CONCLUSION IS THAT THE EVENT WAS NOT RELATED TO A PRODUCT DEFICIENCY. AT THE TIME OF THIS REPORT, THE OFFICIAL AUTOPSY RESULTS AND THE TOXICOLOGY REPORT HAVE NOT BEEN MADE AVAILABLE TO FRESENIUS KABI. FRESENIUS KABI HAS NOT FOUND ANY EVIDENCE SUGGESTING THE AURORA PLASMAPHERESIS SYSTEM HAD ANY CAUSALITY WITH THE DONOR FATALITY.

    Description of Event or Problem · 1

    DONOR WAS A (B)(6) MALE, 6' TALL AND (B)(6) LBS. TOTAL # OF DONATIONS WERE 95, BEGINNING IN 2018. PER CUSTOMER, APPROXIMATELY ONE HOUR AFTER COMPLETING A DONATION AT THE CENTER ON (B)(6) 2021, THE DONOR WAS FOUND IN HIS CAR IN THE PARKING LOT OF THE DONOR CENTER UNCONSCIOUS AND PULSELESS. RESUSCITATION ATTEMPTS WERE MADE BY BOTH THE MEDICAL CENTER STAFF AND THE (B)(6) FIRE DEPARTMENT PARAMEDICS BUT WERE UNSUCCESSFUL. THE DONOR WAS PRONOUNCED DECEASED AT 3:19 PM. THE PRELIMINARY IMPRESSION FROM THE MEDICAL EXAMINER-CORONER'S OFFICE BASED ON THE INVESTIGATION THUS FAR, IS THAT THIS MAY REPRESENT AN ACCIDENTAL DRUG OVERDOSE. AT THE TIME OF THIS REPORT, THE OFFICIAL AUTOPSY RESULTS AND THE TOXICOLOGY REPORT HAVE NOT BEEN MADE AVAILABLE TO FRESENIUS KABI. IF RECEIVED, THIS CONCLUSION WILL BE RE-ASSESSED. DETAILED REVIEW OF THE DONATION RECORDS DATING BACK TO (B)(6) 2021 REVEALED THAT THE DONOR'S DONATIONS WERE WELL TOLERATED. THE DONOR HAD NO DOCUMENTED ADVERSE EVENTS DURING HIS ENTIRE DONATION HISTORY. NO DEFERRAL TRENDS WERE NOTED. IN GENERAL, IT APPEARS THAT THE DONOR TOLERATED THE PLASMAPHERESIS PROCEDURE WELL. THE DEVICE WAS EVALUATED, AND NO DEVICE MALFUNCTIONS WERE OBSERVED. BATCH REVIEWS WERE WITHOUT EXCEPTION. FRESENIUS KABI HAS NOT FOUND ANY EVIDENCE SUGGESTING THE AURORA PLASMAPHERESIS SYSTEM HAD ANY CAUSALITY WITH THE DONOR FATALITY. HOWEVER, AT THIS TIME, FRESENIUS KABI IS CHOOSING TO REPORT CONSERVATIVELY AS THE OFFICIAL AUTOPSY RESULTS AND THE TOXICOLOGY REPORT HAVE NOT BEEN MADE AVAILABLE TO FRESENIUS KABI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612066 AURORA PLASMAPHERESIS SYSTEM AURORA PLASMAPHERESIS SYSTEM GKT FENWAL INTERNATIONAL INC. N/A FA21F30017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death