BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 22154568 · Received June 5, 2025

    Report

    Report Number
    3012307300-2025-06695
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 5, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586027536
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 4012767 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 PUMP DID NOT ALARM, AND THE BAG WAS STILL FULL WHEN THE PUMP WAS DISCONNECTED. SETTINGS WERE REVIEWED: CONTINUOUS INFUSION RATE OF 23.2 ML/HOUR, TOTAL RESERVOIR VOLUME OF 588 ML, THE AIR DETECTOR AND UPSTREAM SENSOR HAD BOTH BEEN TURNED ON, LENGTH OF INFUSION HAD BEEN SET FOR 24HOURS, AND THE LOCK LEVEL WAS 2. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333028 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4012767 10610586027536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown