BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA SPECTRUM

    MDR report key: 2183751 · Received July 25, 2011

    Report

    Report Number
    MW5021521
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 21, 2011
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD HEPARIN DRIP INFUSING WITH SIGMA SPECTRUM PUMP. STAFF CHECKED ABOUT ONE HOUR AFTER INFUSION STARTED AND THERE WAS NO MEDICATION INFUSING AND BLOOD WAS BACKING UP INTO TUBING. PUMP INDICATED THAT IT WAS INFUSING, BUT IT WASN'T. CHANGED TO ANOTHER PUMP AND IT WORKED FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention