BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA PUMP

    MDR report key: 159654 · Received March 25, 1998

    Report

    Report Number
    1314492-1998-00003
    Event Type
    Death
    Date Received
    March 25, 1998
    Date of Event
    February 21, 1998
    Report Date
    February 25, 1998
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE DISPENSED INACCURATE LEVEL OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA PUMP IV PUMP FRN SIGMA INTERNATIONAL 6000+ VOLUMETRIC PUMP *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death