BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 3131672 · Received May 6, 2013

    Report

    Report Number
    1722139-2013-00804
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP WAS TESTED FOR ACCURACY SEVERAL TIMES, USING WATER. PUMP DELIVERED AMOUNT WITHIN SPECIFICATION (SPECIFICATION IS +/-5%). PUMP'S ROTOR HAS TEAL SILICONE RESIDUE FROM THE DISPOSABLE SET. ROTOR WAS REPLACED. AS A PREVENTATIVE MEASURE, PUMP WAS RE-TESTED AND PASSED ALL TESTS INCLUDING ACCURACY TEST. COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT PUMP INFUSED ONLY TEN PERCENT OF FORMULA. CUSTOMER DID NOT KNOW AN EXACT AMOUNT AND REFUSED TO PROVIDE FURTHER INFO. RATE AND DOSE PROVIDED ARE 65 ML/HR AND INFINITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197905 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MED DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR TOLEREX