BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 24589930 · Received March 13, 2026

    Report

    Report Number
    3012307300-2026-02380
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    January 26, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3/H6: THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE EVENT HISTORY LOG WAS REVIEWED. THE REPORTED ISSUE WAS CONFIRMED THROUGH EVENT LOG. THE DEVICE WAS VISUALLY INSPECTED. A FUNCTIONAL TEST WAS PERFORMED. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO CAM FLEX SENSOR. AS A RESULT, THE CAM FLEX SENSOR 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.

    Description of Event or Problem · 0

    US SR 3883002 WAS OPENED REGARDING A CADD-SOLIS VIP AMBULATORY INFUSION PUMP WITH LN 21-2120-0105-01 AND SN (B)(6): IT WAS REPORTED THAT THE PUMP UNIT DISPLAYED ERROR CODE 41622. THE EVENT OCCURRED DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648765 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown