BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY

    MDR report key: 3231172 · Received June 20, 2013

    Report

    Report Number
    3231172
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP (ZEVEX)
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INFINITY FEEDING PUMPS ARE SUPPOSED TO ALARM WHEN 5 OR MORE INCHES OF AIR ARE SENSED IN THE SENSOR OF THE PUMP. THE PATIENT'S FEEDING BAG WAS COMPLETELY EMPTY PAST THE PUMP AND THE PUMP DID NOT ALARM THAT THERE WERE NO FEEDS IN THE BAG. THE PUMP SHOULD HAVE ALARMED THAT THE BAG WAS EMPTY. THIS PUMP DID HAVE MORE THAN 5 INCHES OF AIR WHEN DISCOVERED. NO PATIENT HARM OCCURRED AS AIR DID NOT REACH THE PATIENT. THERE HAVE BEEN THREE EVENTS WITH THIS DEVICE AT THIS FACILITY WITHIN ONE MONTH.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?FEEDING PUMP.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279539 ENTERALITE INFINITY PUMP, INFUSION, ENTERAL LZH MOOG MEDICAL DEVICES GROUP (ZEVEX) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO