BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2061025 · Received April 4, 2011

    Report

    Report Number
    1722139-2011-00052
    Event Type
    Other
    Date Received
    April 4, 2011
    Report Date
    April 2, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS INITIATED BUT HAS NOT BEEN COMPLETED. THIS INITIAL REPORT IS BEING SUBMITTED TO MEET THE 30 DAY REPORTING REQUIREMENT. UPON COMPLETION OF THE EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED; PUMP CONTINUES TO RUN AFTER THE FOOD IS GONE. PATIENT INJURY OR MEDICAL INTERVENTION, NO INJURY REPORTED. ADDITIONAL PATIENT INFORMATION: PUMP FEED RATE 70 ML/HR AND DOSE 493 ML. CONTINUOUS BOLUS, FEEDING 180 ML AT A TIME INTO THE BAG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK