BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2961532 · Received January 17, 2013

    Report

    Report Number
    1722139-2013-00099
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 17, 2012
    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

    INVESTIGATION FOUND THAT PUMP WAS TESTED FOR ACCURACY SEVERAL TIMES, USING WATER. PUMP DELIVERED AMOUNT WITHIN SPEC (SPEC IS +/- 5%). COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT PUMP IS NOT INFUSING THE CORRECT VOLUME. IT DELIVERED 7 ML INSTEAD OF 10 ML AT RATE 500 ML/HR USING WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26128 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1