BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD -SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 3080834 · Received April 12, 2013

    Report

    Report Number
    2183502-2013-00143
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    MEA
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 44.510. THEREFORE, THE MAIN CIRCUIT BOARD WAS REPLACED. FOLLOWING REPAIR, 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 PT INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159803 CADD -SOLIS AMBULATORY INFUSION PUMP MEA - PUMP, INFUSION, PCA MEA SMITHS MEDICAL MD 2100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1