BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY 500

    MDR report key: 2875037 · Received November 12, 2012

    Report

    Report Number
    2875037
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP (ZEVEX)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DELIVERY SET WAS PRIMED WITH ENTERAL SUBSTANCE. NURSE NOTED THAT THE MILK WAS DRIPPING FROM THE TUBING ONTO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY 500 PUMP, INFUSION, ENTERAL, TUBING FRN MOOG MEDICAL DEVICES GROUP (ZEVEX) INF0500 CF21608 OR CF1216714

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES