BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS HPCA PUMP

    MDR report key: 23597671 · Received November 19, 2025

    Report

    Report Number
    3012307300-2025-12619
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    September 23, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    MEA
    UDI-DI
    15019517128734
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ONE DEVICE WAS RETURNED FOR ANALYSIS. FUNCTIONAL AND VISUAL TESTS WERE PERFORMED, AND THE REPORTED ISSUE WAS DUPLICATED. THE LOCK MECHANISM WAS NOT WORKING, AND THE CARTRIDGE COULD NOT BE REMOVED. HOWEVER, REVIEW OF THE EVENT HISTORY REVEALED ERROR CODE 46228 INDICATING A FAILURE OF THE PRINTED WIRE ASSEMBLY (PWA). THIS INDICATED A REPORTABLE MALFUNCTION BASED ON THE PWA. THE PWA WILL BE REPLACED TO ADDRESS THIS ISSUE. 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 READING MECHANISM WAS BROKEN, AS IT WAS NOT POSSIBLE TO REMOVE THE CARTRIDGE FROM THE PUMP. PER REPORTER, THERE WAS NO PATIENT INVOLVEMENT, AND THE ISSUE WAS DISCOVERED DURING TESTING. EVALUATION OF THE RETURNED DEVICE IDENTIFIED ERROR CODE 46228 INDICATING A PRINTED WIRE ASSEMBLY (PWA) FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310221 CADD-SOLIS HPCA PUMP PUMP, INFUSION, PCA MEA ICU MEDICAL, INC. 2110 15019517128734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown