BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11699965 · Received April 21, 2021

    Report

    Report Number
    3012307300-2021-03336
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 21, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESTIMATED LOT NUMBER IS 4040250.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, THE CUSTOMER NOTICED A NO DISPOSABLE, CLAMP TUBING ALARM. IT WAS ALSO NOTED THAT THE TUBING WAS FOUND TO BE TWISTED AND AFTER STRAIGHTENING IT OUT AND CHANGING TO ANOTHER PUMP, THE SITUATION WAS SETTLED. IT WAS ALSO REPORTED THAT PER CUSTOMER, THE DISPOSABLE WAS ATTACHED TO A CADD PUMP, AND THE PUMP ALARMED. HOWEVER, AFTER REPLACING THE DISPOSABLE WITH A NEW ONE, THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597865 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1