BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LZH PUMP, INFUSION, ENTERAL

    MDR report key: 1203622 · Received October 16, 2008

    Report

    Report Number
    1527460-2008-00881
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K943733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTS AN UNDER DELIVERY. IT WAS REPORTED THAT THE FLOW RATE WAS SET AT 200 ML/HR. AFTER ONE HR 15 MIN, THE ACTUAL VOLUME FED WAS 168 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LZH PUMP, INFUSION, ENTERAL PATROL PUMP LZH ABBOTT NUTRITION 52036

    Patients

    Seq Age Sex Outcome Treatment
    1