BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION

    MDR report key: 20510046 · Received October 22, 2024

    Report

    Report Number
    3012307300-2024-11763
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 22, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586020315
    PMA / PMN Number
    K942046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR ANALYSIS OF THIS COMPLAINT. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 6012583 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 WAS HOOKED UP TO THE PUMP, BUT THE PATIENT KEEPS GETTING OCCLUSION ERRORS. 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
    2566707 CADD EXTENSION SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 6012583 10610586020315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown