BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 24308868 · Received February 10, 2026

    Report

    Report Number
    3012307300-2026-01128
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 13, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO PRODUCT RETURNED FOR DEVICE ANALYSIS; A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING HAD BEEN FOUND BROKEN APPROXIMATELY 6 INCHES BELOW THE CONNECTION CLOSEST TO THE PORT, AND CHEMOTHERAPY HAD BEEN OBSERVED LEAKING FROM THE SITE. THE PUMP HAD BEEN POWERED OFF, AND THE CLAMP NEAREST THE PORT HAD BEEN CLOSED. CHEMOTHERAPY SPILL INSTRUCTIONS HAD BEEN REVIEWED, AND THE PATIENT HAD BEEN ADVISED TO CALL THE PHYSICIAN CLINIC IMMEDIATELY PER SFI. IT HAD BEEN REPORTED BY THE CHEMOTHERAPY NURSE THAT THE LEAK WAS LOCATED A COUPLE OF INCHES AWAY FROM WHERE THE TUBING HAD BEEN ATTACHED TO THE PUMP. THERE WAS NO INJURY. THE MEDICATION HAD BEEN 5-FU. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368881 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown