BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PCA AMBULATORY INFUSION SYSTEM

    MDR report key: 19487836 · Received June 7, 2024

    Report

    Report Number
    3012307300-2024-04762
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 1, 2024
    Report Date
    June 7, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    UDI-DI
    10610586019357
    PMA / PMN Number
    K982839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED. A VISUAL INSPECTION FOUND THE DEVICE IN GOOD CONDITION WITH NO PHYSICAL DAMAGE. DURING THE FUNCTIONAL TESTING, THE DEVICE SHOWED LEC 1816 AFTER POWER UP. THE MOTOR WILL BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP DISPLAYED 'ERROR CODE LEC 1816'. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107134 CADD LEGACY PCA AMBULATORY INFUSION SYSTEM PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 6300 10610586019357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown