BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA

    MDR report key: 405275 · Received July 18, 2002

    Report

    Report Number
    MW1025603
    Event Type
    Death
    Date Received
    July 18, 2002
    Date of Event
    April 8, 2001
    Report Date
    July 17, 2002
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT DIED AS A RESULT OF CATCHING ON FIRE, WHILE A PT IN THE HOSP. FAMILY BELIEVES THAT THE PT RECEIVED A ONE-INCH BURN TO THE BACK OF THEIR HEAD, AS THE ENTRY POINT, OF AN ELECTRICAL SPARK, WHICH MIGHT HAVE STARTED THE FIRE. THEY DISCOVERED THAT THE HOSP USES THE SIGMA 6000 INFUSION PUMP. THE HEPLOCK WAS REPORTED TO HAVE MELTED ON THE PT'S RIGHT WRIST. THIS HOSP USES THE SIGMA 6000 INFUSION PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA INFUSION PUMP/ OR I-V FRN SIGMA INTERNATIONAL 6000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death