BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 24389038 · Received February 19, 2026

    Report

    Report Number
    1722139-2026-00061
    Event Type
    Death
    Date Received
    February 19, 2026
    Date of Event
    January 22, 2026
    Report Date
    January 22, 2026
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    UDI-DI
    10814844000075
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO MMD FOR EVALUATION. A DHR REVIEW WAS NOT COMPLETED BECAUSE THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. BECAUSE THE DEVICE WAS NOT RETURNED, MMD HAS BEEN UNABLE TO INVESTIGATE THE COMPLAINT. THIS REPORT WILL BE UPDATED WHEN THE DEVICE IS RETURNED TO MMD.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATES THAT THE PATIENT HAD PASSED AWAY WHILE IN A NURSING HOME DUE TO ASPIRATION. THEY STATED THAT THEY BELIEVED THAT THE PATIENT WAS NOT BEING ADEQUATELY CARE FOR AND THAT THIS LED TO THE PATIENT ASPIRATING. THEY DID NOT REPORT ANY PROBLEM OR MALFUNCTION WITH THE DEVICE. THEY STATED THAT THEY BELIEVED THE PATIENTS FEEDINGS WERE NOT BEING STARTED AND STOPPED AS PRESCRIBED AND THEY ARE REQUESTING THAT THE PUMP LOG BE DOWNLOADED AND REVIEWED. AT THIS TIME, THE INITIAL REPORTER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION ABOUT THE EVENT OR THE PATIENT'S DEATH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449266 ENTERALITE INFINITY ENTERAL FEEDING PUMP ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFKIT2 N/A 10814844000075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death