BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 17694986 · Received September 6, 2023

    Report

    Report Number
    3004548776-2023-00309
    Event Type
    Death
    Date Received
    September 6, 2023
    Date of Event
    August 8, 2023
    Report Date
    August 8, 2023
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    LKN
    PMA / PMN Number
    K111702
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FRESENIUS KABI RECEIVED A REPORT OF A PATIENT FATALITY FROM (B)(6). THE INCIDENT OCCURRED, WHILE THE PATIENT WAS ON THE AMICUS INSTRUMENT (MODEL 6R4580, SERIAL NUMBER (B)(6)), USING AN AMICUS THERAPEUTIC PLASMA EXCHANGE (TPE) KIT (MATERIAL X6R2349, BATCH FA22C28132). ACCORDING TO THE FMC SHREVEPORT NURSE MANAGER, THE PATIENT HAD CODED BEFORE COMING IN FOR THE PLASMA EXCHANGE. DUE TO THE PATIENT'S "AGGRESSIVE ANCA VASCULITIS AND RAPID DETERIORATION" THE PATIENT'S DOCTOR (AFTER A LONG DISCUSSION WITH THE PATIENT'S FAMILY AND CRITICAL CARE TEAM) DECIDED TO PERFORM TPE. NEAR THE END OF THE TPE PROCEDURE, THE PATIENT CODED AGAIN. THE MEDICAL STAFF FOLLOWED THEIR PROCEDURES FOR "CODE BLUE" AND "RAPID RESPONSE", HOWEVER, THE PATIENT DID NOT SURVIVE. (B)(6) REPORTS NO ALARMS OCCURRED, DURING THE TPE PROCEDURE. THE FOLLOWING PATIENT MEDICAL HISTORY INFORMATION WAS PROVIDED TO FRESENIUS KABI BY (B)(6): ACUTE KIDNEY INJURY SUPER IMPOSED ON CHRONIC KIDNEY DISEASE GLOMERULONEPHRITIS DETERMINED BY BIOPSY. WHICH SHOWED NECROTIZING GLOMERULONEPHRITIS, HAD RECEIVED RITUXAN DOSES. ANEMIA, HYPERTENSION, PERONEAL DEEP VEIN THROMBOSIS, GENERAL WEAKNESS, RESPIRATORY FAILURE WITH HYPOXIA. CARDIOPULMONARY ARREST X 3 BEFORE STARTING THE TPE PROCEDURE ON AMICUS DIFFUSE PULMONARY ALVEOLAR HEMORRHAGE. AFTER A REVIEW OF THE EVENTS AND PROCEDURE DATA, THE FRESENIUS KABI SYSTEMS ENGINEERING TEAM DETERMINED, THE AMICUS WAS OPERATING AS INTENDED AND ALL PARAMETERS WERE WITHIN THE EXPECTED RANGES. ALL EVENTS THAT OCCURRED WERE RESOLVED BY THE OPERATOR. AND ALLOWED THE PROCEDURE TO CONTINUE AS EXPECTED. THE BATCH RECORD FOR THE AMICUS TPE KIT USED, DURING THE DONATION (MATERIAL X6R2349, BATCH FA22C28132) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167496 AMICUS SEPARATOR SYSTEM AMICUS THERAPEUTIC PLASMA EXCHANGE KIT LKN FENWAL INTERNATIONAL INC. N/A FA22C28132

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death