BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 8000

    MDR report key: 154327 · Received March 4, 1998

    Report

    Report Number
    154327
    Event Type
    Injury
    Date Received
    March 4, 1998
    Date of Event
    February 6, 1998
    Report Date
    March 4, 1998
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFUSION PUMP DEVIATED FROM PROGRAMMED RATE. OVERINFUSION OF PITOCIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention