BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO

    MDR report key: 19797 · Received August 31, 1994

    Report

    Report Number
    2243621-1994-05241
    Event Type
    Injury
    Date Received
    August 31, 1994
    Date of Event
    August 1, 1994
    Report Date
    August 18, 1994
    Manufacturer
    CGH
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES BLOOD LEAK DURING DIALYSIS. RN REPORTS LEAK OCCURRED AFTER FIVE MINUTES OF TREATMENT. PT LOST 250CC OF BLOOD. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO HEMODIALYZER FJI CGH ICSL 40518N11

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention