BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 3172765 · Received May 31, 2013

    Report

    Report Number
    2183502-2013-00281
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    MEA
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RECEIVED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED ERROR CODE 44510. THEREFORE, THE LATEST REVISION OF SOFTWARE WAS DOWNLOADED. FOLLOWING SOFTWARE UPGRADE, THE DEVICE PASSED ALL FUNCTION AND DELIVERY TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED THE PUMP ALARMED "ERROR CODE 44510." NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242216 CADD-SOLIS AMBULATORY INFUSION PUMP MEA - PUMP, INFUSION, PCA MEA SMITHS MEDICAL MD NA 1007313

    Patients

    Seq Age Sex Outcome Treatment
    1