BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION MED PUMP

    MDR report key: 1836190 · Received September 13, 2010

    Report

    Report Number
    MW5017414
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MEDEXINC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRALIPIDS INFUSING VIA MEDFUSION SYRINGE PUMP SET AT 0.8 CC/H AS ORDERED. THEN 23 CO SYRINGE HUNG AT 2200 ON 9/6. UPON DOING HOURLY CHECKS AT 0900 ON 9/7, NOTICED 20 CC REMAINED IN SYRINGE, BUT PUMP WAS MAKING IT APPEAR IT WAS ACTUALLY INFUSING. WATCHED SYRINGE FOR THE FOLLOWING HOUR, NO CHANGE IN VOLUME OF SYRINGE, ALTHOUGH PUMP STATED VOLUMES HAD BEEN INFUSING. LIPIDS PLACED ON A DIFFERENT PUMP, AND THE OTHER PUMP REMOVED FROM SERVICE FOR BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION MED PUMP FRN MEDEXINC 67350

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA