BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21-2120-0103-01

    MDR report key: 20779184 · Received November 26, 2024

    Report

    Report Number
    3012307300-2024-14055
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 25, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517084368
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED; DAY IS UNKNOWN. ONE DEVICE WAS RECEIVED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. THE PUMP HAS A BUBBLED DOWNSTREAM OCCLUSION (DSO) SEAL, AND IT IS PULLED UP ON THE EDGES. THE DSO WAS REPLACED, AND THE SOFTWARE VERSION WAS UPDATED. THE DEVICE PASSED FUNCTIONAL TESTING AFTER THE REPAIRS. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICES DOWNSTREAM OCCLUSION (DSO) IS PEELING OFF AND IT NEED TO BE UPDATED TO 1.6 VERSION. DISCOVERED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572657 21-2120-0103-01 PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517084368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown