BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 2176721 · Received July 19, 2011

    Report

    Report Number
    2176721
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SIGMA SPECTRUM INFUSION PUMPS EXPERIENCING BEARING FAILURE. SIGMA'S SOLUTION OF USING BACK FLOW VALVE CANNOT BE APPLIED TO PEDIATRIC POPULATION DUE TO INABILITY TO USE IN NEONATES. UNDER-INFUSION ISSUES OF UP TO 40% MAY OCCUR BECAUSE OF MID/HIGH PRESSURE REQUIREMENT. CANNOT GIVE BLOOD OR TAKE BLOOD SAMPLES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *