BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11876163 · Received May 25, 2021

    Report

    Report Number
    3012307300-2021-04984
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 25, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF CASSETTE: 4092491.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, A SMITHS MEDICAL CADD PUMP EXHIBITED NO DISPOSABLE FOUND ALARM. IT WAS ALSO REPORTED THAT THE PATIENT RETURNED TO THE CLINIC THE NEXT MORNING AND MEDICATION WAS DISPENSED USING AN EMPTY BAG AND A DIFFERENT SET OF TUBING. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772959 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1