BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA SPECTRUM

    MDR report key: 689428 · Received February 14, 2006

    Report

    Report Number
    689428
    Event Type
    Death
    Date Received
    February 14, 2006
    Date of Event
    February 1, 2006
    Report Date
    February 9, 2006
    Manufacturer
    SIGMA SPECTRUM INTL.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PUMP DID NOT INFUSE HEPARIN CAUSING PT TO HAVE STROKES. PT DIED LATER FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM VOLUMETRIC INFUSION PUMP FRN SIGMA SPECTRUM INTL. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death