BEUDAMED
    FDA Adverse Event Other Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 746781 · Received July 12, 2006

    Report

    Report Number
    MW1039700
    Event Type
    Other
    Date Received
    July 12, 2006
    Date of Event
    June 27, 2006
    Report Date
    July 12, 2006
    Manufacturer
    GAMBRO
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THREE DIFFERENT PATIENTS WERE UNDERGOING DIALYSIS AT AN OUTPATIENT LOCATION ON THREEE DATE. THE BLOOD SET CARTRIDGES CAUSED BLOOD LEAKS ON ALL THREE PATIENTS. NO INJURY OCCURRED AND THE PTS WERE SWITCHED TO OTHER MACHINES.

    Description of Event or Problem · 2

    THREE DIFFERENT PATIENTS WERE UNDERGOING DIALYSIS AT AN OUTPATIENT LOCATION ON THE DATES OF 6/27/06, 7/3/06, AND 7/4/06. THE BLOOD SET CARTRIDGES CAUSED BLOOD LEAKS ON ALL THREE PATIENTS. NO INJURY OCCURRED AND THE PATIENTS WERE SWITCHED TO OTHER MACHINES.

    Description of Event or Problem · 3

    THREE DIFFERENT PATIENTS WERE UNDERGOING DIALYSIS AT AN OUTPATIENT LOCATION ON THE DATES OF 6/27/06, 7/3/06, AND 7/4/06. THE BLOOD SET CARTRIDGES CAUSED BLOOD LEAKS ON ALL THREE PATIENTS. NO INJURY OCCURRED AND THE PATIENTS WERE SWITCHED TO OTHER MACHINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO CARTRIDGE BLOOD SET DIALYSIS LINE FJK GAMBRO * 014M-15701

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other
    2 * Other
    3 * Other