BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDD-SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 3814996 · Received April 24, 2014

    Report

    Report Number
    2183502-2014-00248
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    MEA
    PMA / PMN Number
    K072144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RECEIVED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD AND TESTING OF THE DEVICE CONFIRMED. ERROR CODE-44510. THEREFORE, THE 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
    248123 CDD-SOLIS AMBULATORY INFUSION PUMP MEA - PUMP, INFUSION, PCA MEA SMITHS MEDICAL 21-2110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1