BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 23369283 · Received October 23, 2025

    Report

    Report Number
    3012307300-2025-11745
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    July 24, 2025
    Report Date
    January 23, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D1 - BRAND NAME, D2A - COMMON DEVICE NAME, D2B - PROCODE, D4 - MODEL #, D4 - CATALOG #, D4 - PRIMARY UDI NUMBER, G4 - PMA/510(K) #, H4 - DEVICE MFG DATE, AND H6 - INVESTIGATION FINDINGS: CORRECTION. UPDATED INVESTIGATION: ITEM NUMBER FOUND TO BE WRONG: ACTUAL PUMP IS 21-2120-0102-51 BUT, IN THE SYSTEM, IT WAS 21-2112-0401-78.

    Additional Manufacturer Narrative · 0

    H3: ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED THE DEVICE WAS IN USED CONDITION. SERVICE HISTORY IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING WAS PERFORMED, AND THE REPORTED ISSUE WAS DUPLICATED. THE CAUSE WAS TRACED TO A NON-REACTIVE DOWNSTREAM OCCLUSION (DSO) SENSOR. THE DSO SENSOR WAS REPLACED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP HAD A CASSETTE ERROR. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE FOUND A NON-REACTIVE DOWNSTREAM OCCLUSION SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506082 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown