BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2191847 · Received July 29, 2011

    Report

    Report Number
    1722139-2011-00107
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM TESTING FOR THIS PUMP WAS REVIEWED AND FOUND TO BE FUNCTIONING NORMALLY. ALL ALARMS FUNCTIONED ACCORDING TO SPECS. VOLUMETRIC ACCURACY WAS FOUND TO BE WITHIN SPEC. SEVERAL TESTS WERE RUN WITH PEDIASURE AT THE SETTINGS USED BY THE CUSTOMER. EACH TIME WHEN THE BAG WAS EMPTY, THE PUMP STOPPED AND ALARMED NO FOOD. THE CUSTOMER COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE PUMP DOES NOT STOP WHEN THE BAG IS EMPTY. PT'S MOTHER STATED THEY USED PEDIASURE AT 40ML/HR FOR 720ML. MOTHER ALLEGED THE PUMP KEPT RUNNING AFTER THE FORMULA WAS GONE AND NO ALARM SOUNDED. SHE IMMEDIATELY TURNED OFF THE PUMP AND USED A BACK UP PUMP BEFORE AIR COULD BE PUMPED INTO THE PT. THE PT'S CONDITION OF 'FAILURE TO THRIVE' WAS NOT CHANGED BY THE EVENT AND NO INTERVENTION WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR