BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14150312 · Received April 19, 2022

    Report

    Report Number
    3012307300-2022-06678
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 16, 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
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH LEGACY PUMPS ALARMING NO DISPOSABLE CLAMP TUBING LOT 4220003. NO INJURY. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272102 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4220003 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown