BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2885443 · Received December 12, 2012

    Report

    Report Number
    1722139-2012-01223
    Event Type
    Death
    Date Received
    December 12, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AUTOPSY REPORT L12-056 BUMO RELATING TO MDR 1722139-2012-01223 WAS PROVIDED BY FDA TO MMDG ON OCTOBER 29, 2015 DURING A MEETING BETWEEN MMDG AND FDA. MMDG AGREED TO REASSESS THE MDR IN LIGHT OF THE PROVIDED AUTOPSY REPORT. COMPLAINT 8913 AND MDR 1722139-2012-01223 HAVE BEEN REASSESSED BY MMDG PERSONNEL IN LIGHT OF THE ADDITIONAL INFORMATION PROVIDED BY FDA. THE CONCLUSION OF THE ASSESSMENT IS THAT THERE IS NO INDICATION OF PUMP MALFUNCTION DURING THE REPORTED EVENT. SALIENT POINTS FROM THE INVESTIGATION PERFORMED IN OCTOBER 2012,, ARE AS FOLLOWS: -- THE PUMP LOG COVERS THE LAST 4 FEEDINGS DELIVERED BY THE DEVICE -- AT ALL TIMES, THE PUMP WAS PROGRAMMED TO DELIVER 1200 ML AT 60 ML/HR -- THE "INFINITE DOSE" SETTING WAS NOT USED -- THE FIRST FEEDING COVERED BY THE LOG WAS DELIVERED IN A TOTAL OF 20.135 HR WITH 1200 ML DELIVERED FOR A RATE OF 59.6 ML/HR -- AT ONE POINT DURING THE FIRST FEEDING, THE PUMP WAS COMMANDED TO STOP BY THE OPERATOR AND WAS THEN RESTARTED BY THE OPERATOR -- THE SECOND FEEDING WAS DELIVERED IN A TOTAL OF 19.987 HR WITH 1200 ML DELIVERED FOR A RATE OF 60.0 ML/HR. -- AT ONE POINT DURING THE SECOND FEEDING, THE PUMP WAS COMMANDED TO STOP BY THE OPERATOR AND WAS THEN RESTARTED BY THE OPERATOR -- THE THIRD FEEDING WAS DELIVERED IN A TOTAL OF 15.652 HR WITH APPROXIMATELY 940 ML DELIVERED FOR A RATE OF 60.1 ML/HR -- THE THIRD FEEDING WAS INTERRUPTED BY AN AIR IN LINE "NO FOOD" ALARM AT 15.952 HR. AT THIS POINT, THE FEEDING WAS PAUSED AND THE PUMP SHUT OFF. AN AIR IN LINE "NO FOOD" ALARM USUALLY OCCURS WHEN THERE IS NO FOOD LEFT IN THE RESERVOIR. THE PUMP OPERATED PROPERLY AND PAUSED WHEN THE "NO FOOD" ALARM WAS TRIGGERED. -- THE FOURTH AND FINAL FEEDING WAS DELIVERED IN A TOTAL OF 19.986 HR WITH 1200 ML DELIVERED FOR A RATE OF 60.0 ML/HR. MMDG'S CONCLUSION IN LIGHT OF THE ADDITIONAL INFORMATION PROVIDED BY FDA IS THAT THE PUMP OPERATED ACCORDING TO SPECIFICATIONS DURING THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PUMP WAS DELIVERED WITH THE PROGRAMMED VOLUME AND RATE WITH NO ERRORS. THE BATTERY WAS CHARGED PROPERLY THE DURATION OF THE LOG. CUSTOMER DOES NOT STATE THAT THE PUMP MALFUNCTIONED.

    Description of Event or Problem · 1

    DISTRIBUTOR REQUESTS ASSISTANCE IN REVIEWING THE DEVICE HISTORY TO INVESTIGATE AN AUTOPSY ON A (B)(6) CHILD WHO DIED WHILE USING THE ENTERALITE INFINITY PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death