BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 17794821 · Received September 21, 2023

    Report

    Report Number
    3004548776-2023-00316
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    April 26, 2023
    Report Date
    September 21, 2023
    Manufacturer
    FENWAL INTERNATIONAL INC.
    Product Code
    GKT
    PMA / PMN Number
    BK960005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FRESENIUS KABI RECEIVED A REPORT THAT DUE TO A CITRATE REACTION DURING AN APHERESIS PROCEDURE, CALCIUM CARBONATE 500MG (TUMS) AND SALINE WAS GIVEN TO A DONOR HALFWAY THROUGH THE PROCEDURE. THE DONOR REPORTED FEELING BETTER AND THE DONATION CONTINUED. AT THE END OF THE DONATION, THE DONOR PRESENTED WITH PARESTHESIA, STIFFNESS IN HANDS AND FEET, NUMBNESS OF THE FACE AND A TINGLING SENSATION. THE DONOR WAS THEN GIVEN ANOTHER 500MG CALCIUM CARBONATE TABLET. NO IMPROVEMENT WAS EVIDENCED, SO THE DONOR WAS SENT TO THE EMERGENCY DEPARTMENT. IN THE EMERGENCY DEPARTMENT, SERUM TESTS WERE PERFORMED, AND LOW LEVELS OF CALCIUM WERE FOUND. NO ADDITIONAL INFORMATION WAS ABLE TO BE ASCERTAINED FOR THIS EVENT AND IT IS UNKNOWN WHAT TREATMENT WAS RECEIVED BY THE DONOR IN THE EMERGENCY ROOM. IT WAS REPORTED THAT THEY WERE HOSPITALIZED FOR A DAY AND A HALF. ALTHOUGH THESE ARE KNOWN POSSIBLE SIDE EFFECTS OF AN APHERESIS PROCEDURE, FRESENIUS KABI IS REPORTING THIS EVENT CONSERVATIVELY AS IT IS NOT KNOWN WHAT TREATMENT THE DONOR WAS GIVEN IN THE HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060696 AMICUS SEPARATOR SYSTEM AMICUS PLATELET KIT GKT FENWAL INTERNATIONAL INC. FA23B14083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization