BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PCA PUMP

    MDR report key: 18725410 · Received February 16, 2024

    Report

    Report Number
    3012307300-2024-00842
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 1, 2024
    Report Date
    February 16, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3, G4, D4: UDI UNKNOWN. E1 INITIAL REPORTER PHONE: (B)(6). ONE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND THE DEVICE TO BE WORN, AND THE DISPLAY HAD GLUE RESIDUE. A REVIEW OF THE EVENT HISTORY LOG FOUND A RECORD OF "HIGH PRESSURE", "POWER LOST WHILE PUMP WAS ON", "LEC 1870", "LEC 1836" AND "LEC 1872" ALARM MESSAGES. FUNCTIONAL TESTING VERIFIED THE REPORTED PROBLEM. IT WAS DETERMINED THE MOST PROBABLE CAUSE WAS THE MAIN BOARD. THE MAIN BOARD WAS REPLACED. THE SERVICE HISTORY REVIEW IDENTIFIED NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE EXHIBITED ERROR 1836. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432512 CADD LEGACY PCA PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 6300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown