BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 22926531 · Received August 29, 2025

    Report

    Report Number
    3012307300-2025-10154
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3: DEVICE NOT RECEIVED BY MANUFACTURER. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE WAS RECEIVED FOR EVALUATION. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE WAS LAST SERVICED IN SEP/2024 PER SR # 3141956 BUT 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 CONFIRMED IN THE EVENT HISTORY LOG BUT NOT DUPLICATED THROUGH TESTING. 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 DISPLAYED ERROR CODE 41786. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2879516 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown