BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 21463937 · Received February 25, 2025

    Report

    Report Number
    3012307300-2025-02215
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 1, 2025
    Report Date
    February 25, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    15019517161953
    PMA / PMN Number
    K031361
    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: 6012528 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 PATIENT ARRIVED EARLY FOR A BAG CHANGE BECAUSE THE FILTER WAS LEAKING. THE TOTAL VOLUME WAS 1,091 ML, WITH A RATE OF 23 ML/HR. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME. NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994855 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6012528 15019517161953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DOXORUBICIN 42 MG/21 ML.| ETOPOSIDE 200 MG/10 ML.| NS 1,058 ML.| VINCRISTINE 1.6 MG/1.6 ML.