BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE

    MDR report key: 22211965 · Received June 16, 2025

    Report

    Report Number
    3012307300-2025-07140
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 1, 2025
    Report Date
    July 18, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586032370
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER PHONE. (B)(6). 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.

    Additional Manufacturer Narrative · 0

    ONE USED SAMPLE WITH LIST # 21-7308-24, RESERVOIR, CASSETTE, AND 250ML FS ATTACHED TO ONE (1) USED EXTENSION SET WAS RETURNED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED NO DAMAGE OR ANOMALIES. TO REPLICATE CLINICAL USE, THE CASSETTE WAS FILLED WITH 200ML OF WATER USING AN ICU MEDICAL PROVIDED SYRINGE, REATTACHED TO THE EXTENSION SET MATING DEVICE, AND INSERTED INTO A CAD SOLIS PUMP (SERIAL #1041296). THE CASSETTE WAS PRIMED WITH 10 ML. NO DIFFICULTIES FILLING THE CASSETTE WERE OBSERVED. ADDITIONALLY, NO ALARMS OR DIFFICULTIES PRIMING WERE OBSERVED. THE COMPLAINT OF DOWNSTREAM OCCLUSION ALARMS CANNOT BE REPLICATED OR CONFIRMED. A DEVICE HISTORY REVIEW FOUND NO DISCREPANCIES OR ANOMALIES RELEVANT TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CASSETTE RESERVOIR EXHIBITED DOWNSTREAM OCCLUSION. TROUBLESHOOTING WAS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009446 CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6061513 10610586032370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown