BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14458310 · Received May 20, 2022

    Report

    Report Number
    3012307300-2022-09246
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 20, 2022
    Report Date
    May 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH CADD LEGACY PUMPS ALARMED -NO DISPOSABLE- WITH SAME CASSETTE. ADVISED THE PATIENT TO MIX NEW CASSETTE AND ATTEMPT THE INFUSION AGAIN. PATIENT DECLINES NURSE OFFER TO STAY ON LINE, HE WANTS TO CALL BACK; PATIENT WAS ANXIOUS TO RESTART INFUSION. NO LOT NUMBER INFORMATION WAS COLLECTED AT THIS TIME; THE LOT NUMBER WILL BE OBTAIN DURING RETURN CALL. NEW CASSETTE INFUSING WITHOUT ISSUE ON INITIAL PUMP THAT ALARMED. AFFECTED CASSETTE LOT NUMBER 4220003, EXP 11/24/22. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764227 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4220003 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown