BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 2800888 · Received September 27, 2012

    Report

    Report Number
    2800888
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MEDEX, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SYRINGE PUMP ALARMED SAYING "MOTOR MALFUNCTION." PUMP WAS INFUSING MILRINONE. RN CHECKED THE SYRINGE AND NOTICED THAT NO VOLUME HAD INFUSED TO THE PATIENT. THE PUMP WAS PROGRAMMED CORRECTLY AND WAS DISPLAYING THE CORRECT VOLUME DELIVERED. THE MILRINONE SYRINGE WAS CHANGED THE DAY PRIOR, BUT THERE REMAINED A FULL 50ML IN THE SYRINGE. THIS WAS DIFFICULT TO NOTICE BECAUSE THE MEDICATION WAS INFUSING AT A RATE ON 0.263ML/HR. RN IMMEDIATELY SWITCHED PUMPS AND TAGGED THE DEFECTIVE ONE FOR MAINTENANCE.UPON CLINICAL ENGINEERING INVESTIGATION IT WAS CONFIRMED THE PUMP HISTORY INCLUDED "MOTOR RATE ERROR". CLINICAL ENGINEERING REPROGRAMMED THE EXACT INFUSION USING A 60 CC SYRINGE AND AT THE END THE PUMP ALARMED "RATE BELOW RECOMMENDED MINIMUM FOR SYRINGE SIZE". THE RATE WAS 0.263 ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION PUMP, INFUSION, SYRINGE FRN MEDEX, INC. 3500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *