BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOOG ZEVEX ENTERAL

    MDR report key: 1981188 · Received February 2, 2011

    Report

    Report Number
    MW5019273
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ZEVEX
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS USING AN INFINITY FOOD PUMP FOR ENTERAL FEEDINGS AND FOUND THE PUMP TO BE PUMPING OUT OF THE STOMACH AND INTO THE FILL BAG DUE TO THE PUMP SET CONFIGURED THE WRONG WAY. DOSE: 237 ML, FREQUENCE: 4 TIMES A DAY. DATES OF USE: (B)(6) 2009 - (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: GASTROSTOMY STATUS, PERINATAL CHRONIC RESPIRATORY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOOG ZEVEX ENTERAL INFO500 ENTERAL PUMP DELIVERY SET LZH ZEVEX INFO500 CF1027502

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Life Threatening| S