BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 22323340 · Received June 24, 2025

    Report

    Report Number
    3012307300-2025-07615
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    15019517096378
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE EVENT HISTORY LOG (EHL) WAS REVIEWED. THE DEVICE WAS VISUALLY INSPECTED. FUNCTIONAL AND VISUAL TESTS WERE PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE MAIN BOARD. AS A RESULT, THE MAIN BOARD WAS REPLACED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE DEVICE PASSED ALL FUNCTIONAL TESTING AFTER REPAIR AND WAS RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    H3, H6: 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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY GOT DEVICE BACK FROM REPAIR, DURING START UP THE DEVICE HAS A RED SCREEN WITH ERROR 45984 AND 85122, 0, 0, 3. THIS ALARM EVENT PAUSES THE DELIVERY OF THE PUMP UNTIL THE ERROR IS ADDRESSED. THE EVENT HAPPENED UPON POWER ON, AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998453 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 2120 15019517096378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown