BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 21942148 · Received May 1, 2025

    Report

    Report Number
    3012307300-2025-05092
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    January 1, 2025
    Report Date
    May 1, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 2183161-2025-00041. THE DATE OF THAT SUBMISSION WAS 3/4/2025. H3: THE DEVICE WAS RECEIVED FOR EVALUATION. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. THE CUSTOMER'S STATED PROBLEM WAS NOT CONFIRMED. THE PUMP WAS WORKING PROPERLY. THERE WAS NO KNOWN CAUSE OF THE REPORTED ISSUE, AND NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A RED SCREEN WITH ERROR CODE 41786. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208696 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITH¿S MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown