BEUDAMED
    FDA Adverse Event Other Summary report: N

    C 121

    MDR report key: 23699 · Received January 5, 1994

    Report

    Report Number
    2243621-1993-00277
    Event Type
    Other
    Date Received
    January 5, 1994
    Date of Event
    November 6, 1993
    Report Date
    December 28, 1993
    Manufacturer
    TERUMO CORPORATION
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    15 MIN AFTER INTITATION OF THE TREATMENT, THE PT COMPLAINED OF SOB AND WHEEZING. HIS BLOOD PRESURE WENT UP TO 240/120. THE TREATMENT WAS DISCONTINUED ON THIS DIALYZER AND RESTARTED ON ANOTHER. THE PT HAD NO FURTHER PROBLEMS. THIS WAS THE PT'S FIRST TREATMENT IN-CENTER. HE HAD BEEN ON A THREE OTHER DIALYZERS AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C 121 HOLLOW FIBER HEMODIALYZER FJI TERUMO CORPORATION C 121 8893H203

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other COBE CENTURY 2 DIALYSIS MACHINE