BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 600

    MDR report key: 262075 · Received February 8, 2000

    Report

    Report Number
    1314492-2000-00002
    Event Type
    Death
    Date Received
    February 8, 2000
    Date of Event
    January 6, 2000
    Report Date
    February 8, 2000
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING INFUSED LIDOCAINE FROM A 500 ML BAG USING A SIGMA 6000 IV PUMP. THE INFUSION STARTED AT 12:30PM IN 2000 AT A RATE OF 30 ML/HR. RATE WAS CHANGED TO 15 ML/HR AT APPROX 5:15 THAT SAME DAY. AT APPROX 6:00PM IN 2000, THE NURSE HEARD THE PUMP ALARMING AND ENTERED THE ROOM, NURSE FOUND A RELATIVE OF THE PT IN THE ROOM. THE DOOR WAS OPEN ON THE IV PUMP OPEN AND FLUID WAS FREE-FLOWING INTO THE PT. THE NURSE IMMEDIATELY CLOSED THE DOOR TO THE IV PUMP AND BEGAN RESUSCITATION OF THE PT. ATTEMPTS TO REVIVE THE PT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 600 INFUSION PUMP FRN SIGMA INTERNATIONAL 6000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death