BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRUM IV PUMP

    MDR report key: 789015 · Received July 10, 2006

    Report

    Report Number
    789015
    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 RETRIEVED FROM HOLDING AREA TO REPLACE PUMP ON PT WITH BATTERY DEPLETION. THIS IV PUMP WAS PLUGGED INTO THE WALL OUTLET IN HOLDING AREA. IT WOULD TURN ON EVEN WHEN PLUGGED IN. 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. UNABLE TO DETERMINE BATTERY CAPACITY. THE STRAIN RELIEF BRACKET INTACT. ONLY ONE SCREW. THE GREEN LED LIGHT ON THE TRANSFORMER (PLUG) IN NOT ON. BATTERY CONTACTS ALL CLEAN, NO CORROSION ON ANY PADS (+0000-) THE CONTACT PINS ( THE BOTTOM PIN, THIRD COLUMN FROM THE RIGHT IS PUSHED IN SLIGHTLY AS COMPARED TO THE OTHERS) BATTERY LOT NO. 34705D. THE STRAIN RELIEF BRACKET HAS ONLY SCREW TO HOLD IN PLACE, ON THE BOTTOM. NEEDS TWO ON THE UPPER EDGE OF THE BRACKET. WHEN THE CORD/ TRANSFORMER UNIT REPLACED, LED LIGHT GOES ON AND IV PUMP IS ABLE TO BE TURNED ON. UNABLE TO GET A READING FROM THE BATTERY CAPACITY. ALL FINDINGS REPORTED TO SIGMA ON 06-06-06.

    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