BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO HEALTHCARE

    MDR report key: 197462 · Received November 18, 1998

    Report

    Report Number
    197462
    Event Type
    Injury
    Date Received
    November 18, 1998
    Date of Event
    November 10, 1998
    Report Date
    November 10, 1998
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE RN HOOKING PT UP FOR DIALYSIS (HEMODIALYSIS) THE BLOOD LINE BECAME UNATTACHED TO NEEDLE LINE RESULTING IN APPORX 50-100 CC OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO HEALTHCARE BLOODLINE (COBE CARTRIDGE) FJK GAMBRO HEALTHCARE * 81605N

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention