BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2250945 · Received August 31, 2011

    Report

    Report Number
    1722139-2011-00296
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    May 27, 2010
    Report Date
    June 11, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP ROTOR WAS INSPECTED AND FOUND ONE ROLLER DID NOT SPIN FREELY. THERE WAS A STICKY SUBSTANCE ON THE ROLLER CAUSING ROLLER TO NOT SPIN FREELY. THE UNDER DELIVERY WAS CONFIRMED. THE PUMP ROTOR WAS REPLACED TO RESOLVE THE ISSUE. THIS REPORT IS PART OF A RETROSPECTIVE REVIEW FOR REPORTABILITY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR STATED THE CUSTOMER ALLEGED THE PUMP WAS UNDER DELIVERING. THE DISTRIBUTOR TESTED THE PUMP WITH WATER, BUT STATED THE CUSTOMER HAS PROBLEM WITH THE FOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1