BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2250943 · Received August 31, 2011

    Report

    Report Number
    1722139-2011-00297
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    September 27, 2010
    Report Date
    October 19, 2011
    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

    EXAMINATION OF THE PUMP SHOWED DRIED FORMULA AROUND THE TOP HOUSING AND DRIED FLUID INSIDE THE SENSOR HOUSING. THE TOP HOUSING HAD A CRACK NEAR THE AIR IN LINE SENSOR AREA WHICH MAY HAVE ALLOWED FLUID INSIDE AND CONTRIBUTED TO THE AREA. THE PUMP WAS SERVICED AND RECALIBRATED, THEN TESTED SEVERAL TIMES WITH WATER, ELE CARE, ENSURE PLUS AND OSMOLITE AND ALARMED 'AIR' EACH TIME. THE ROOT CAUSE OF THE CRACK WAS ATTRIBUTED TO A MANUFACTURING ERROR WHERE THE AIR SENSOR TOP HOUSING AREA WAS OVERLOADED IN COMPRESSION BY THE AIR SENSOR HOUSING CAUSING THE CRACK. THIS REPORT IS PART OF A RETROSPECTIVE REVIEW FOR REPORTABILITY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR STATED, THE CUSTOMER INDICATED, THE PUMP DID NOT GIVE AN 'AIR' ALARM WHEN AIR WAS IN THE LINE. THE PATIENT'S FEED WAS SET AT 170 ML/HR, TURNED OFF AND THEN RESTARTED AT A SLOWER RATE OF 150 ML/HR. THE PATIENT NOTICED A LOT OF AIR IN THE FEED, 2 HOURS LATER AND THE PUMP HAD NOT ALARMED TO INDICATE THIS.

    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