BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 22575506 · Received July 23, 2025

    Report

    Report Number
    3012307300-2025-08844
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 23, 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

    THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 6061497 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. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP ALARMED NO DISPOSABLE. PER REPORTER, A CONTINUOUS INFUSION RATE OF 23 ML/HOUR HAD BEEN PROGRAMMED, WITH A TOTAL RESERVOIR VOLUME OF 520 ML. THE AIR DETECTOR HAD BEEN TURNED ON AND THE UPSTREAM SENSOR HAD BEEN TURNED OFF. THE LENGTH OF INFUSION WAS 23 HOURS AND 30 MINUTES. REPORTER STATED THE TUBING WAS PRIMED MANUALLY. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938748 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6061497 10610586027536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown