BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14456828 · Received May 20, 2022

    Report

    Report Number
    3012307300-2022-09234
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 19, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "NO DISPOSABLE" ALARM WAS DISPLAYED ON BOTH PUMPS WHILE USING CADD 100 ML CASSETTE WITH FLOW STOP. REPORTED LOT NUMBER IS 4230866 AND REPORTED EXPIRATION DATE IS 12/27/2026. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581687 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4230866. 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown