BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 3173494 · Received June 12, 2013

    Report

    Report Number
    1722139-2013-01894
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP HAS BEEN TESTED SEVERAL TIMES USING WATER, AND EACH TIME WHEN BAG WAS EMPTY PUMP STOPPED PUMPING AND ALARMING NO FOOD (OR PUMP FINISH DOSE: ALARMING "DOSE DONE"). ALL ALARMS HAVE BEEN CHECKED AND WORK PROPERLY. COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT DURING TESTING PUMP CONTINUES TO RUN OVER A FEW MILLIMETERS AFTER THE DOSE SHOULD HAVE BEEN DONE. PUMP DID NOT ALARM. RATE AND DOSAGE ARE 500 ML/HR AND 10ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265253 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1