BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14288914 · Received May 5, 2022

    Report

    Report Number
    3012307300-2022-07596
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 4, 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

    Narratives

    Description of Event or Problem · 0

    (2/2, REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING CASSETTE IT WAS REPORTED THAT A CADD LEGACY 6400 NO DISPOSABLE PUMP ALARM USING CASSETTE LOT NUMBER 4220003, EXPIRATION 11/24/2026 WAS EXPERIENCED. CADD LEGACY PUMP SERIAL NUMBER (B)(4). PUMP REPLACEMENT SENT. NO FURTHER DETAILS PROVIDED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379118 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4220003 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown