BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM

    MDR report key: 2468930 · Received February 15, 2012

    Report

    Report Number
    2468930
    Event Type
    Malfunction
    Date Received
    February 15, 2012
    Date of Event
    February 11, 2012
    Report Date
    February 15, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PUMP SUDDENLY READ "SYSTEM ERROR 345 THEMISTOR DISPARITY". THE PUMP REQUIRED POWER DOWN AND COMPLETE PUMP RESTART. IT LOST ALL INPUT PROGRAMMING EACH TIME. IT HAPPENED TWICE THROUGH THE NIGHT. PATIENT REQUIRED EXTRA LAB DRAW FOR INTERNATIONAL NORMALIZED RATIO (INR) DUE TO UMP BEING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM INFUSION PUMP FRN SIGMA 35700BAX *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR