BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 22644806 · Received July 29, 2025

    Report

    Report Number
    3012307300-2025-09050
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 29, 2025
    Manufacturer
    SMITH¿S MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN: 2183161-2025-00025. THE DATE OF THAT SUBMISSION WAS 20-FEB-2025. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS FUNCTIONALLY TESTED, BUT THE INVESTIGATION COULD NOT DUPLICATE THE REPORTED ISSUE. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCE'S NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE FILTER AND HOSE WERE REPLACED AS A PREVENTATIVE MEASURE.

    Description of Event or Problem · 0

    ERROR 46228; 250129-000278.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356089 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITH¿S MEDICAL ASD, INC. 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown