BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 3121676 · Received May 11, 2013

    Report

    Report Number
    3121676
    Event Type
    Malfunction
    Date Received
    May 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SMITH'S MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    NURSE WAS CHECKING THE SYRINGE TO SEE WHEN IT WOULD BE EMPTY AND NEED TO BE CHANGED. IT WAS EXPECTED TO BE LOW AND IT WAS FOUND TO HAVE 13CC OF SOLUTION IN THE SYRINGE. THE MEDICATION IS MILRINONE (0.1MG/ML). IT WAS HUNG AT 0300 AND SHOULD HAVE BEEN RUNNING AT 1.6CC/HOUR. IF IT RAN AT THAT RATE FOR 12 HOURS THERE SHOULD HAVE BEEN ABOUT 1CC LEFT IN THE SYRINGE. BIOMED WAS PAGED AND THEY SAID THEY WOULD NOT COME AND GET THE PUMP. NURSE SUPERVISOR SAID TO PLACE THE PUMP IN THE DIRTY SUPPLY ROOM, THAT BIOMED WILL LOOK AT IT LATER. MEDICAL TEAM INFORMED THAT MILRINONE DRIP WAS NOT INFUSING FOR SEVERAL HOURS ~ 7 HOURS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MEDICATION ADMINISTRATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209824 MEDFUSION PUMP, INFUSION FRN SMITH'S MEDICAL 3500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 DAY