BEUDAMED
    FDA Adverse Event Summary report: N

    CENTRAL VENOUS PRESSURE MONITOR

    MDR report key: 20035 · Received February 28, 1995

    Report

    Report Number
    MW1005278
    Date Received
    February 28, 1995
    Date of Event
    February 28, 1995
    Report Date
    February 28, 1995
    Manufacturer
    EDWARDS DIV., BAXTER HEALTHCARE COORP.
    Product Code
    KRK
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ABOVE THE LAST PORT OF CVP TUBING, A POSSIBLE AIR LEAK CAUSES AIR TO ENTER TUBING AND IV FLUID TO LEAK. THIS HAPPENED 2 TIMES WITH SAME LOT NUMBER. POTENTIAL AIR TO THE PT. (DIFFERENT LOT # THAN REPORTED ON 2/23/95).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL VENOUS PRESSURE MONITOR MONITOR KRK EDWARDS DIV., BAXTER HEALTHCARE COORP. Y4L164, Y4H063

    Patients

    Seq Age Sex Outcome Treatment
    1 *