BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1901142 · Received November 3, 2010

    Report

    Report Number
    1901142
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 3, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    BAG OF TPN HUNG APPEARED TO BE FULL DESPITE IT BEING RUN THROUGH A PUMP THAT APPEARED TO BE WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INFUSION PUMP FRN SIGMA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR