BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 20772066 · Received November 25, 2024

    Report

    Report Number
    3012307300-2024-13916
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 25, 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE POSSIBLE LOTS IN WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A LEAK IN THE TUBING. THE PUMP HAD BEEN RUNNING, WITH THE RESERVOIR VOLUME EMPTYING IN 37 HOURS AND 50 MINUTES. THE PUMP HAD BEEN STOPPED AND POWERED OFF. THE CLAMP NEAR THE PORT HAD BEEN CLOSED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. POSSIBLE LOT NUMBERS: 6022103, 6026886.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014075 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. UNKNOWN 10610586020315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown