BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 1870326 · Received September 23, 2010

    Report

    Report Number
    1870326
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 23, 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

    BURETROL FOR TOTAL PARENTERAL NUTRITION (TPN) DID NOT EMPTY DURING INFUSION FROM 0830 TO 0900.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *