BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 1900969 · Received October 15, 2010

    Report

    Report Number
    1900969
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 15, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    CHECKED IV PUMP WITH TACROLIMUS INFUSION AT 0800. MACHINE WAS TURNED OFF; APPROXIMATELY 175 ML OF FLUID IN TACROLIMUS BAG. FLUID DUE TO BE CHANGED AT 1330.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *