BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMBI SET TRUE FLOW SERIES

    MDR report key: 561700 · Received December 23, 2004

    Report

    Report Number
    561700
    Event Type
    Other
    Date Received
    December 23, 2004
    Date of Event
    October 6, 2004
    Report Date
    December 23, 2004
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKJ
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ESTIMATED 20 CC BLOOD LOSS DUE TO THE LINE SEPARATION WHERE THE N/S, NORMAL SALINE, PIGTAIL TEES INTO THE ARTERIAL PORTION OF THE DIALYSIS TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBI SET TRUE FLOW SERIES DIALYSIS LINES AND BLOOD TUBING FKJ FRESENIUS MEDICAL CARE NORTH AMERICA 03-2622-3 70-1411-01

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR