BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS HPCA PUMP

    MDR report key: 20446509 · Received October 14, 2024

    Report

    Report Number
    3012307300-2024-11090
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 1, 2024
    Report Date
    October 14, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR ANALYSIS. REVIEW OF THE EVENT HISTORY LOG (EHL) SHOWED A CASSETTE NOT ATTACHED (NDA) PROPERLY ALARM. A FUNCTIONAL TEST WAS PERFORMED AND THE REPORTED ISSUE WAS NOT DUPLICATED, HOWEVER A NDA WAS CONFIRMED IN THE HISTORY LOG. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE DOWNSTREAM SENSOR. AS A RESULT, THE DOWNSTREAM SENSOR WAS REPLACED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A CASSETTE SENSOR ERROR. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208645 CADD SOLIS HPCA PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown