BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 8000

    MDR report key: 1063417 · Received June 19, 2008

    Report

    Report Number
    MW5007372
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 19, 2008
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FREE FLOW SIGMA IV PUMP SIGMA: ECN LEVEL 03805. PATIENT REC'D CARDIZEM 250ML BAG WHICH WAS HUNG AT 1120 - ENTIRE BAG INFUSED BY 1350 SETTING ON PUMP: > 12.5 MG / HOUR, > 170 VOLUME LIMIT, > 29.6 VOLUME DELIVERED. PUMP IMMEDIATELY SECURED AND TAKEN TO "BIO - MED" OFFICE AND CO. CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 8000 IV PUMP FRN SIGMA INTERNATIONAL SIGMA 8000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization