BEUDAMED
    FDA Adverse Event Death Summary report: N

    AURORA XI PLASMAPHERESIS SYSTEM

    MDR report key: 17101018 · Received June 9, 2023

    Report

    Report Number
    3004548776-2023-00169
    Event Type
    Death
    Date Received
    June 9, 2023
    Date of Event
    December 20, 2022
    Report Date
    July 21, 2023
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    PMA / PMN Number
    BK160028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INITIAL MDR INFORMATION: ON MAY 12, 2023 BIOMAT COLUMBUS REPORTED A DONOR FATALITY WHICH OCCURRED ON (B)(6), 2022. DONOR WAS A 36-YEAR-OLD MALE WHO HAD DONATED 99 TIMES SINCE (B)(6), 2019. DONOR WAS 5'11" AND 332 LBS. HE WAS DEFERRED 4 TIMES FOR OUT-OF-RANGE PULSE AND DIASTOLIC BLOOD PRESSURE VALUES BETWEEN (B)(6) 2022 AND (B)(6) 2022. LAST DONATION OCCURRED ON DECEMBER 05, 2022. DONATION WAS WITHOUT COMPLICATION AND 894ML OF PLASMA WAS COLLECTED. DONOR RECEIVED 500ML OF SALINE AFTER COLLECTION. THE DEATH CERTIFICATE STATES THE IMMEDIATE CAUSE OF THE DONOR'S DEATH TO HAVE BEEN AN ACUTE RESPIRATORY FAILURE, DUE TO SEPTIC SHOCK, AS A CONSEQUENCE OF AN ACUTE CEREBRAL VASCULAR ACCIDENT, AS A CONSEQUENCE OF AN ACUTE DEEP VEIN THROMBOSIS. NO AUTOPSY WAS PERFORMED. THE AURORA XI DEVICE WAS UNABLE TO BE ANALYZED FOR THE DAY OF DONATION ((B)(6) 2022), AS THE FATALITY ((B)(6) 2022) WAS REPORTED ALMOST 5 MONTHS AFTER THE DONATION OCCURRED. A TECHNICIAN DID GO TO THE SITE ON (B)(6), 2023 AND FOUND THE DEVICE TO BE WORKING AS INTENDED. BATCH REVIEW FOR THE AURORA XI KIT WAS WITHOUT EXCEPTION. BASED ON MISSING THE HOSPITAL ADMISSION DATE, MISSING MEDICAL RECORDS, AND THAT THE DEVICE WAS UNABLE TO BE ANALYZED FOR THE DAY OF DONATION, THERE IS NOT ENOUGH INFORMATION TO RULE OUT THE DONATION AS A CONTRIBUTING FACTOR. OTHER FACTORS TO CONSIDER ARE THE DONOR'S MORBID OBESITY AND FAMILY HISTORY OF BLOOD CLOTS (PER DONOR'S GIRLFRIEND) AS BEING SIGNIFICANT CONTRIBUTORS TO THE FATALITY. FOLLOW-UP MDR INFORMATION: NO SAMPLE OR PICTURES WERE RECEIVED BY FRESENIUS KABI FOR EVALUATION. AS A RESULT, NO CONCLUSIVE OR POTENTIAL ROOT CAUSE OF THE EVENT COULD BE IDENTIFIED. A BATCH REVIEW WAS COMPLETED FOR MATERIAL 6R2600, BATCH FA22I26042. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS EVENT. FRESENIUS KABI HAS MADE 3 ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION. THE LAST INQUIRY WAS MADE ON JUNE 09, 2023 REQUESTING THE HOSPITAL ADMISSION DATE. BASED ON THE RESPONSE FROM THE CUSTOMER, FRESENIUS KABI HAS BEEN INFORMED THAT THERE IS NO ADDITIONAL INFORMATION AND THAT A FORMAL REQUEST FOR THE MEDICAL RECORDS HAS BEEN MADE. AS OF THE DATE OF THIS REPORT, FRESENIUS KABI HAS NOT RECEIVED THE MEDICAL RECORDS. IF THE ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP SHALL BE SUBMITTED.

    Description of Event or Problem · 0

    ON MAY 12, 2023 BIOMAT COLUMBUS REPORTED A DONOR FATALITY WHICH OCCURRED ON (B)(6) 2022. DONOR WAS A 36-YEAR-OLD MALE WHO HAD DONATED 99 TIMES SINCE (B)(6) 2019. DONOR WAS 5'11" AND 332 LBS. HE WAS DEFERRED 4 TIMES FOR OUT-OF-RANGE PULSE AND DIASTOLIC BLOOD PRESSURE VALUES BETWEEN (B)(6) 2022. LAST DONATION OCCURRED ON (B)(6) 2022. DONATION WAS WITHOUT COMPLICATION AND 894ML OF PLASMA WAS COLLECTED. DONOR RECEIVED 500ML OF SALINE AFTER COLLECTION. THE DEATH CERTIFICATE STATES THE IMMEDIATE CAUSE OF THE DONOR'S DEATH TO HAVE BEEN AN ACUTE RESPIRATORY FAILURE, DUE TO SEPTIC SHOCK, AS A CONSEQUENCE OF AN ACUTE CEREBRAL VASCULAR ACCIDENT, AS A CONSEQUENCE OF AN ACUTE DEEP VEIN THROMBOSIS. NO AUTOPSY WAS PERFORMED. THE AURORA XI DEVICE WAS UNABLE TO BE ANALYZED FOR THE DAY OF DONATION ((B)(6) 2022), AS THE FATALITY ((B)(6) 2022) WAS REPORTED ALMOST 5 MONTHS AFTER THE DONATION OCCURRED. A TECHNICIAN DID GO TO THE SITE ON MAY 17, 2023 AND FOUND THE DEVICE TO BE WORKING AS INTENDED. BATCH REVIEW FOR THE AURORA XI KIT WAS WITHOUT EXCEPTION. BASED ON MISSING THE HOSPITAL ADMISSION DATE, MISSING MEDICAL RECORDS, AND THAT THE DEVICE WAS UNABLE TO BE ANALYZED FOR THE DAY OF DONATION, THERE IS NOT ENOUGH INFORMATION TO RULE OUT THE DONATION AS A CONTRIBUTING FACTOR. OTHER FACTORS TO CONSIDER ARE THE DONOR'S MORBID OBESITY AND FAMILY HISTORY OF BLOOD CLOTS (PER DONOR'S GIRLFRIEND) AS BEING SIGNIFICANT CONTRIBUTORS TO THE FATALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151408 AURORA XI PLASMAPHERESIS SYSTEM AUTOMATED BLOOD CELL SEPARATORS GKT FENWAL INTERNATIONAL INC. N/A FA22I26042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death