BEUDAMED
    FDA Adverse Event Other Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 742490 · Received June 8, 2006

    Report

    Report Number
    2087532-2006-00130
    Event Type
    Other
    Date Received
    June 8, 2006
    Date of Event
    May 9, 2006
    Report Date
    May 9, 2006
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD LOSS. CUSTOMER EXPERIENCED HIGH VENOUS PRESSURE 300-400 D-1 D-2 ALARMS AND FLOW BALANCE ERROR WAS EXPERIENCED. CUSTOMER COULD NOT TELL WHAT ALARM WITH WHAT INCIDENT. THE MACHINES WOULD NOT ALLOW BACK FLUSH WITH VENOUS PRESSURE HIGH. ALL MACHINES INVOLVED WERE CHECKED. CUSTOMER ACCESS SITES WERE CHECKED - CUSTOMER CHECKED NO CLOTTING IN DIALYZERS OR COAGULATION. PT LOST 2 CIRCUITS OF BLOOD. CUSTOMER REPLACED SET AND FINALLY DECIDED TO REMOVE LOT NUMBER IN USE. NO PT DEATHS OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO CARTRIDGE BLOOD SET BLOOD TUBING SET FOR HEMODIALYSIS FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. NA 03M15720

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other