BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14150105 · Received April 19, 2022

    Report

    Report Number
    3012307300-2022-06677
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 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

    Narratives

    Description of Event or Problem · 0

    PER PRODUCT COMPLAINT FORM: INBOUND. PATIENT'S HUSBAND REPORTING CADD LEGACY PUMP ALARMED NO DISPOSABLE CLAMP TUBING. TURNING PUMP OFF AND ON RESOLVED ISSUE TEMPORARILY. PUMP ALARMED WITH SAME ISSUE THREE TIMES, AT WHICH POINT SWITCHED TO NEW CASSETTE AND PUMP. PUMP WORKING WITHOUT ISSUE. CASSETTE LOT 4192062 EXPIRATION 09/02/2026. NO FURTHER ASSISTANCE NEEDED AT THIS TIME. NO FURTHER DETAILS PROVIDED. NO INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719906 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4192062 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown