BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 2510912 · Received March 26, 2012

    Report

    Report Number
    2510912
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    March 26, 2012
    Report Date
    March 26, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    A NEW IV PUMP WAS STARTED ON PATIENT AND BLOOD WAS BACKING UP INTO THE IV TUBING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR