BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 24617923 · Received March 17, 2026

    Report

    Report Number
    3012307300-2026-02529
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    October 27, 2025
    Report Date
    March 17, 2026
    Manufacturer
    ICU MEDICAL S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586029646
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTO WAS PROVIDED. ONE DEVICE WAS RETURNED FOR ANALYSIS. AS RECEIVED ASV VALVE WAS OBSERVED TO BE SEPARATED FROM THE SET TUBING. INSPECTION OF THE BOND LOCATION SHOWED SPOTTY SOLVENT COVERAGE ON THE TUBE. THE TUBE AND LUER WERE FOUND TO MEET MANUFACTURING SPECIFICATIONS. THE COMPLAINT TUBE BREAKING FROM THE CONNECTOR CAN BE CONFIRMED. THE PROBABLE CAUSE IS DUE TO INSUFFICIENT SOLVENT COVERAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CADD ADMINISTRATION SET TUBING BROKE OFF FROM THE CONNECTOR. THE DEVICE WAS PROGRAMMED TO DELIVER A CONTINUOUS INFUSION RATE OF 0.6 ML PER HOUR, WITH A TOTAL RESERVOIR VOLUME OF 84 ML AND A REMAINING VOLUME OF 42.8 ML. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677245 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL S.A. DE C.V. 6071182 10610586029646

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown