BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1940958 · Received December 15, 2010

    Report

    Report Number
    1940958
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 15, 2010
    Manufacturer
    SIGMA SPECTRUM
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT SHOULD HAVE RECEIVED A TOTAL OF 180ML OVER 6 HOURS BUT 350ML OF SOLUTION WAS INFUSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR