BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 25202555 · Received May 18, 2026

    Report

    Report Number
    3012307300-2026-05098
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE EVENT HISTORY LOG (EHL) WAS REVIEWED AND THERE WERE NO ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE DEVICE WAS VISUALLY INSPECTED AND THERE WERE NO DAMAGES. A FUNCTIONAL TEST WAS PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE LATCH/LOCK SENSOR. AS A RESULT, THE DOWNSTREAM OCCLUSION SEAL AND LATCH LOCK SENSOR WERE REPLACED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP DID NOT RECOGNIZE THE LOCK VER.2120-106 DURING TESTING. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS AN ISSUE WITH THE LATCH/LOCK SENSOR. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435342 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown