BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 21143359 · Received January 13, 2025

    Report

    Report Number
    3012307300-2025-00645
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 13, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER SAMPLES NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 6022118 WERE 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 PUMP HAD ALARMED, DISPLAYING A DOWNSTREAM OCCLUSION MESSAGE ON THE SCREEN. IT WAS CONNECTED TO A PATIENT WHEN THE ERROR OCCURRED. THE PATIENT CHECKED FOR KINKS IN THE TUBING BUT FOUND NONE. THE PATIENT RESTARTED INFUSION, AND IT CONTAINED A PARTIAL VOLUME OF INFUSION WITHIN THE CASSETTE AT THE TIME OF DISCONNECTION. THE CONTINUOUS INFUSION RATE WAS 2.2 ML/HR, AND THE TOTAL RESERVOIR VOLUME WAS 101 ML. THE AIR DETECTOR AND UPSTREAM SENSOR STATUSES WERE NOT SPECIFIED. THE INFUSION LASTED FOR 46 HOURS, AND THE LOCK LEVEL WAS SET TO LOCKED. A SYRINGE WAS USED TO PRIME THE EXTENSION TUBING. NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987143 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 6022118 10610586023279

    Patients

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