BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD -SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 2945186 · Received December 26, 2012

    Report

    Report Number
    2183502-2012-00593
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    MEA
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. INVESTIGATION WAS ABLE TO VERIFY THE CUSTOMER'S COMPLAINT OF ERROR CODE 44510. WHEN POWERED UP THE DEVICE DISPLAYED ERROR CODE 44510 WITH A CONTINUOUS ALARM. THE ERROR CODE ALARM WAS DETERMINED TO HAVE BEEN CAUSED BY THE MALFUNCTION OF THE PUMP CIRCUIT BOARD. AFTER REPAIR AND RECALIBRATION THE DEVICE WAS FOUND TO PASS ALL DELIVERY, ACCURACY AND FUNCTIONAL TESTS CORRUPTION.

    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
    1 CADD -SOLIS AMBULATORY INFUSION PUMP MEA - PUMP, INFUSION, PCA MEA SMITHS MEDICAL MD 2120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE