BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14288964 · Received May 5, 2022

    Report

    Report Number
    3012307300-2022-07598
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 3, 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

    IT WAS REPORTED CADD CASSETTE 100 ML WITH FLOW-STOP , LOT 4220003, EXP: 11/24/2026; WITH RESERVOIR VOLUME 86.3 ML REMAINING RESULTED IN UNRESOLVED NO DISPOSABLE CLAMP TUBING ALARMS ON BOTH PUMPS. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569254 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4220003 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown