BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA 8000

    MDR report key: 276073 · Received April 28, 2000

    Report

    Report Number
    1314492-2000-00003
    Event Type
    Other
    Date Received
    April 28, 2000
    Date of Event
    April 4, 2000
    Report Date
    April 27, 2000
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING AN INFUSION OF PROCLAMINE USING A SIGMA MODEL 8000 INFUSION PUMP AT A RATE OF 125 ML/HR THE SAME PUMP HAD BEEN USED FOR THE PRECEDING 15 HOURS. AT 3:20 PM PN 4/4/2000, A NEW 500 ML BAG WAS HUNG AND THE PUMP WAS RESTARTED. IT WAS REPORTED TO HAVE BEEN FOUND TO FREE-FLOW. A SECOND PUMP WAS USED AND WAS FOUND TO BE OPERATING CORRECTLY. PT'S INFUSION WAS CONTINUED ON THE SECOND PUMP AT A LOWER RATE TO PREVENT OVERLOADING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other