BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 1901113 · Received October 29, 2010

    Report

    Report Number
    1901113
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AT 0340 PATIENT STARTED ON VITAMIN K INFUSION OF 10 MG TO RUN OVER 10 HOURS. PUMP SET AT 10 CC/HR. AT 0540, PUMP ALARMED THAT INFUSION COMPLETE AND BAG WAS EMPTY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *