BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 24313346 · Received February 11, 2026

    Report

    Report Number
    3012307300-2026-01142
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 1, 2026
    Report Date
    February 11, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR ANALYSIS OF COMPLAINT OF INCORRECT LABEL. ANALYSIS FOUND THE REAR WHITE GTIN LABEL STATES ITEM # 21-2127-0104-01. THE CORRECT ITEM # IS 21-2120-0104-01. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. COMPLAINT WAS CONFIRMED DURING POWER UP DEVICE INFORMATION REVIEW. REPLACED THE REAR LABEL AND WHITE GTIN LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ITEM NUMBER 21-2127-0105-01 IS A MANUAL MODE (M) PUMP. HOWEVER, THE REAR LABEL THAT WAS DEBRIEFED DOES NOT MATCH THIS ITEM NUMBER. A BLUE REAR LABEL WAS RECORDED DURING DEBRIEFING, BUT THIS IS INCORRECT. THE CORRECT REAR LABEL FOR THIS PUMP SHOULD BE PART NUMBER 10017409-001. THE PUMP INVOLVED WAS 1182854 ¿ CADD-SOLIS BLUE OR PHARMGUARD WITH MANUAL MODE. THE EVENT OCCURRED UPON POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374347 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown