BEUDAMED
    FDA Adverse Event Summary report: N

    HEMODIALYZER

    MDR report key: 21659 · Received March 31, 1995

    Report

    Report Number
    2243621-1995-05046
    Date Received
    March 31, 1995
    Date of Event
    February 14, 1995
    Report Date
    March 24, 1995
    Manufacturer
    CGH
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES BLOOD LEAK DURING DIALYSIS. RN REPORTS BLOOD LEAK AT ONSET OF ACUTE TREATMENT. BLOOD NOTED IN ARTERIAL SIDE OF DIALYSATE LINE; POSITIVE FOR BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYZER HEMODIALYZER FKP CGH 400HG G1025083

    Patients

    Seq Age Sex Outcome Treatment
    1 *