BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA

    MDR report key: 15952 · Received August 15, 1994

    Report

    Report Number
    15952
    Event Type
    Death
    Date Received
    August 15, 1994
    Date of Event
    July 20, 1994
    Report Date
    July 29, 1994
    Manufacturer
    SIGMA INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH SUSPECTED PULMONARY EMBOLISM ON 7/18. HE WAS PLACED ON HEPARIN THERAPY VIA AN INFUSION PUMP. THE PUMP APPARENTLY HAD A LOW BATTERY AND SHUT ITSELF OFF, DESPITE BEING PLUGGED IN TO A WALL OUTLET. IT WAS OFF FOR APPROX 3 HRS FROM 2130 JULY 19 TO 0030 JULY 20. PT DIED OF A LARGE PULMONARY EMBOLISM AT 11:30 JULY 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA INFUSION PUMP FRN SIGMA INC. SIGMA 6000 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death