BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11781820 · Received May 6, 2021

    Report

    Report Number
    3012307300-2021-03900
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 6, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP HAS HAD AN INCREASE IN "NO DISPOSABLE ALARM". THIS WAS FOUND TO BE ISOLATED TO 21-7302-24 LOTS 4046846 AND 4092491. FOUR CUSTOMERS HAVE EXPERIENCED THIS ISSUE. THE REPORTING COMPLAINT STATES THIS IS NOT AGAINST THE PUMP BUT ISOLATED TO THE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679164 CADD ADMINISTRATION SETS FPA ST PAUL 21-7302-24 4046846 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1