BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 1580758 · Received January 14, 2010

    Report

    Report Number
    1722139-2010-00004
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 14, 2009
    Report Date
    January 12, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MOOG MEDICAL IS ATTEMPTING TO CONTACT THE CUSTOMER AND GATHER MORE INFO ON THE FOOD PREPARATION AND LENGTH OF TIME THE SET WAS IN USE PRIOR TO THE FAILURE. METHOD: ACTUAL DEVICE WAS EVALUATED. RESULTS: THE FAILURE WAS DUPLICATED USING THE SET RETURNED WITH THE PUMP. THE SET WAS VISUALLY INSPECTED UPON RECEIPT AND FOUND TO BE COATED WITH FOOD (MOTHER'S MILK). THE COATING WAS ON THE INSIDE WALL OF THE TUBING IN THE "AIR IN LINE" SENSOR REGION. INITIALLY THE PUMP AND SET WERE TESTED USING THE WATER AND CUSTOMER SETTINGS, RATE 60 ML AND DOSE 1080 ML. THE PUMP DID NOT ALARM "NO FOOD" AND CONTINUED PUMPING. THE SET WAS CLEANED TO REMOVE FOOD AND RETESTED WITH THE SAME PUMP AND SETTINGS. ONCE THE FOOD WAS GONE THE PUMP ALARMED NORMALLY "NO FOOD" AND SHUT OFF. CONCLUSION: IN CONCLUSION, THE ROOT CAUSE OF THE FAILURE CAN BE ATTRIBUTED TO FOOD COATING THE INTERIOR WALL OF THE SET TUBING. THE AIL SENSOR IS AN OPTICAL SENSOR THAT DETECTS THE PRESENCE OR LACK OF LIGHT IN THE RECEIVING SIDE OF THE SENSOR. WHEN FOOD IS FLOWING IN FRONT OF THE SENSOR IT BLOCKS THE LIGHT. WHEN FEEDING IS COMPLETE AIR MOVES IN FRONT OF THE SENSOR ALLOWING LIGHT IN, THE PUMP ALARMS "NO FOOD" AND STOPS RUNNING. IN THIS INCIDENT THE FOOD COATING THE SIDES OF THE TUBING BLOCKED THE LIGHT; AFTER THE FOOD WAS GONE THE SENSOR DID NOT DETECT LIGHT RESULTING IN A NO ALARM SITUATION WHERE THE PUMP CONTINUED TO RUN. THERE ARE SOME SITUATIONS THAT COULD CAUSE THE FOOD TO COAT THE SET TUBING SUCH AS, SET USE BEYOND THE 24 HOUR PERIOD, FOOD COMPOSITION, FOOD STORAGE CONDITIONS, FOOD VISCOSITY. MOOG MEDICAL DEVICES GROUP IS ATTEMPTING TO CONTACT THE PT. IF MORE CUSTOMER/PT INFO BECOMES AVAILABLE, A F/U REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: "CONTINUED TO PUMP WITH EMPTY SET".

    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