BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 12218643 · Received July 23, 2021

    Report

    Report Number
    3012307300-2021-07574
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    June 7, 2021
    Report Date
    July 23, 2021
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONTACT: (B)(6). LOT NUMBER: 4103166.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, AN ALARM WAS NOTED ON THE PUMP. SUBSEQUENTLY, THE PUMP AND CASSETTE WERE CHANGED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116051 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1