BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR, 100ML

    MDR report key: 21885677 · Received April 22, 2025

    Report

    Report Number
    3012307300-2025-04630
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 22, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 6022046 WAS REVIEWED AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING HAD DISCONNECTED BELOW THE CENTRAL PORT AND THE PATIENT WAS BLEEDING. REPORTER STATED THEY FLUSHED THE LINE AND RECONNECTED IT, AND THE PUMP HAD RESUMED RUNNING. THE REPORTER WAS ADVISED TO STOP THE INFUSION. THE EVENT OCCURRED AT THE PATIENT'S HOME. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517834 CADD CASSETTE RESERVOIR, 100ML SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6022046 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLOSED SYSTEM TRANSFER DEVICE.