BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 21422702 · Received February 20, 2025

    Report

    Report Number
    2183161-2025-00025
    Event Type
    Malfunction
    Date Received
    February 20, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE 3012307300-2025-09050-00 FOR DETAILS PERTINENT TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP HAD ERROR CODE 46228. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106307 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITH¿S MEDICAL ASD, INC. 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown