BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 6129825 · Received November 28, 2016

    Report

    Report Number
    1722139-2016-00605
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 31, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO MMDG FOR EVALUTION. NO SERIAL NUMBER WAS PROVIDED AND SO MMDG WAS UNABLE TO EVALUATE OR PERFORM A MANUFACTURING REVIEW. MMDG WAS ADVISED BY THE PATIENT CAREGIVER THAT THEY HAD JUST SWITCHED FORMULAS AND HAD ONLY BEEN EXPERIENCING THIS PROBLEM AFTER BEGINNING TO USE THE NEW FORMULA.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATES THAT THE PUMP SOUNDS LIKE IT IS PRIMING, BUT NOTHING MOVES THROUGH THE PUMP AND THAT THE PUMP ALSO DOESN'T ALARM WHEN THIS HAPPENS. THE INITIAL REPORTER ALSO STATES THAT EVERYTHING WORKS APPROPRIATELY DURING THE FIRST FEEDING WITH A NEW BAG, BUT AFTER THAT THEY EXPERIENCE THE PROBLEM WITH THE PUMP NOT DELIVERING. AN MMDG CLINICIAN FOLLOWED UP WITH THE PATIENT. THE PATIENT DID NOT MISS ANY FEEDINGS AND HAD NO ADVERSE EFFECTS DUE TO THIS COMPLAINT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780103 ENTERALITE INFINITY ENTERAL FEEDING PUMP ENTERAL INFUSION PUMP LZH MOOG MEDICAL DEVICES GROUP INFKIT2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR