BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 24309749 · Received February 10, 2026

    Report

    Report Number
    3012307300-2026-01134
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 1, 2026
    Report Date
    March 9, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    15019517150292
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND THERE WERE NO DAMAGES. A VISUAL INSPECTION WAS PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO INCORRECT SOFTWARE/REAR LABEL. AS A RESULT, THE CORRECT LABEL WAS APPLIED AND CORRECT SOFTWARE INSTALLED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    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 CORRECT SOFTWARE HAD BEEN INSTALLED PRIOR TO SHIPMENT. ITEM NUMBER 21-2127-0105-01 CORRESPONDED TO THE MANUAL MODE (M) CONFIGURATION. HOWEVER, THE REAR LABEL THAT WAS DEBRIEFED DID NOT MATCH THE ITEM NUMBER. A BLUE REAR LABEL WAS RECORDED, WHEREAS THE CORRECT LABEL FOR THIS PUMP SHOULD HAVE BEEN 10017409-001, WHICH APPEARS DIRECTLY ABOVE THE LABEL SHOWN IN THE SCREENSHOT. ITEM 21-2127-0105-01 SHOULD CORRESPOND TO LABEL 10017409-001. THE CADD SOLIS BLACK UNIT WAS RETURNED WITH PHARMGUARD INSTALLED AND A BLUE REAR LABEL APPLIED. THE EVENT HAD OCCURRED UPON POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281669 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 2120 15019517150292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown