BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 8000

    MDR report key: 191742 · Received October 13, 1998

    Report

    Report Number
    1314492-1998-00011
    Event Type
    Death
    Date Received
    October 13, 1998
    Date of Event
    September 14, 1998
    Report Date
    October 12, 1998
    Manufacturer
    SIGMA INTL.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING ADMINISTERED A SALINE INFUSION WITH A SIGMA 8000 INFUSION PUMP. THE RATE PROGRAMMED WAS 50 ML/HR AND A 1000 BAG WAS USED. THE INFUSION WAS STARTED AT 11:30 PM ON 9/13/98. AT 1:30 AM ON 9/14/98 THE PT'S IV BAG WAS REPORTED TO BE EMPTY. PT DIED AT 3:30 AM ON 9/14/98. PT'S DEATH IS NOT BELIEVED TO BE THE RESULT OF THE REPORTED OVERINFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 8000 INFUSION PUMP FRN SIGMA INTL. 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death