BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRUM IV PUMP

    MDR report key: 789034 · Received July 10, 2006

    Report

    Report Number
    789034
    Event Type
    Death
    Date Received
    July 10, 2006
    Date of Event
    June 4, 2006
    Report Date
    June 12, 2006
    Manufacturer
    SIGMA INTERNATIONAL, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SIGMA SPECTRUM PUMP ON PT. IT ALARMED "DEPLETED BATTERY" THEN TURNED OFF. NURSES REPORT THAT THIS HAPPENS FREQUENTLY. THE IV PUMP WAS PLUGGED INTO THE WALL OUTLET. CLINICAL ENGINEERS & RM & NURSING EVALUATED THE PUMP 06-05-06. THIS WAS REPEATED WITH CEO OF SIGMA + LOCAL SIGMA REP ON 06-06-06. THE PUMP WOULD NOT TURN ON. LOW BATTERY WARNING WOULD FLASH. BATTERY CAPACITY 5%. THE PUMP WOULD ONLY TURN ON WHEN THE STRAIN RELIEF BRACKET ON THE BACK WAS PUSHED IN. THE GREEN LED LIGHT ON THE TRANSFORMER (PLUG) IS ON. BATTERY CONTACT ON THE POSITIVE SIDE. BATTERY LOT NO. 31905C. THE STRAIN RELIEF BRACKET ON THE BACK WAS BENT AND CAUSED VARIABLE CONNECTION. LIFTING THE CORD WOULD CAUSE THE CONNECTION TO COMPLETE. THERE IS ONLY ONE SCREW TO HOLD IN PLACE, ON THE BOTTOM. NEEDS TWO ON THE UPPER EDGE ON THE BRACKET. ALL FINDINGS REPORTED TO SIGMA CEO AND LOCAL REP ON 06-06-06 VIA CONFERENCE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM IV PUMP HIGH VOLUME INFUSION PUMP FRN SIGMA INTERNATIONAL, INC. SPECTRUM *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death CARDIAC CATH - OPEN HEART SURGERY.| ACUTE MI.