BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 22793417 · Received August 13, 2025

    Report

    Report Number
    3012307300-2025-09614
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 13, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586029646
    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 6093390 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 HAD INDICATED THERE WAS 0 ML REMAINING, DESPITE THE BAG BEING FULL. PER REPORTER, THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME. REPORTER STATED THAT INFUSION HAD BEEN STARTED WITH 115 ML AT A CONTINUOUS RATE OF 2.5 ML/HR FOR 46 HOURS, WITH THE PUMP WAS DISPLAYING 0 ML REMAINING DESPITE VISIBLE VOLUME STILL PRESENT IN THE BAG. REPORTER STATED THE REMAINING AMOUNT COULD NOT BE MEASURED AS THE PRODUCT WAS CONSIDERED CONTAMINATED ONCE IT LEFT THE CLEAN ROOM. REPORTER STATED THE PUMP AIR DETECTOR HAD BEEN OFF, THE UPSTREAM SENSOR HAD BEEN ON, THE TUBING HAD BEEN PRIMED BY GRAVITY USING A NEEDLE, AND THE PATIENT HAD BEEN MEDICALLY AFFECTED BY NOT RECEIVING THE FULL DOSE OF FLUOROURACIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75992 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6093390 10610586029646

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FLUOROURACIL.