BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUR WAY STOPCOCK

    MDR report key: 1241869 · Received November 19, 2008

    Report

    Report Number
    1241869
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 19, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FMG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO DIFFERENT PATIENTS IN CRITICAL CARE UNIT ON THE SAME DAY. BOTH RECEIVING LEVOPHED AND DIPRIVAN INTRAVENEOUSLY. THE MEDICATION TUBING WAS CONNECTED TO THE PATIENT'S IV WITH A STOPCOCK IN THE LINE. IN BOTH CASES, THE MEDICATIONS LEAKED AT THE STOPCOCK CONNECTION. IN BOTH CASES, THE PATIENT'S BLOOD PRESSURE DROPPED, ONE TO 60 SYSTOLIC. THIS HAPPENED THREE TIMES TO EACH PATIENT IN A 12 HOUR TIME PERIOD. AFTER EACH EVENT, THE STOPCOCK WAS REPLACED AND THE REPLACEMENT ALSO LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUR WAY STOPCOCK STOPCOCK, IV FMG BAXTER HEALTHCARE CORPORATION * UR08E08046 OR KR08E0804

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention CARDIAC DRUGS| CARDIAC DRUGS
    2 64 YR