BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 3113353 · Received April 23, 2013

    Report

    Report Number
    3113353
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 23, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ITEM NUMBERS THAT WERE INVOLVED WERE; 2441-0007 (BURETTE PRIMARY PUMP SET), 2426-0007 (3 PORT PRIMARY PUMP SET) AND MS3500-15 (SECONDARY SET). WHEN THE RN WAS RUNNING A PIGGY BACK SHE WOULD USE THE SECONDARY SET (MS3500-15) AND HOOK THIS INTO THE BURETTE SET (2441-007). SHE NOTICED A LEAK AT THE Y-SITE WHERE THESE TWO ITEMS CONNECTED. SHE THEN TRIED USING THE PRIMARY PUMP SET (2426-0007) AND AGAIN THERE WAS A LEAK. THIS HELPED THE RN IDENTIFY THE ISSUE BEING WITH THE SECONDARY SET (MS3500-15) AND NOT THE OTHER TWO ITEMS.THE FOLLOWING IS RESPONSE FROM OUR AREA ALARIS TUBING REP TO THE HOSPITAL:I HAVE CONTACTED MY CLINICAL NURSING CONSULTANTS THAT COVER SOUTHERN CALIFORNIA BECAUSE THIS SECONDARY SET (MS3500-15) IS USED IN MANY LOCAL FACILITIES. THEY HAVE NOT BEEN NOTIFIED OR SEEN THIS SAME ISSUE IN ANY OTHER FACILITIES. THIS LEADS ME TO BELIEVE THAT HOPEFULLY THIS ISSUE WAS JUST WITH THIS ONE SET AND NOT AN ISSUE WITH A CASE/LOT OF MS3500-15. BASED ON THIS INFORMATION I THINK IT WOULD BE BEST FOR US TO SIMPLY KEEP OUR EYE ON THIS AND SEE IF THE ISSUE HAPPENS AGAIN. I ALSO WILL REPORT TO THIS TO MY CLINICAL ADVOCACY DEPARTMENT WHO WILL FOLLOW UP TO RESEARCH FURTHER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INFUSION OF IVPB TO PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173314 ALARIS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR 3 PORT PRIMARY PUMP SET AND SECONDARY SET| PRIMARY IV TUBING, BURETTE PRIMARY PUMP SET