BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14597823 · Received June 3, 2022

    Report

    Report Number
    3012307300-2022-10695
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    April 24, 2022
    Report Date
    June 3, 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

    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 A -NO DISPOSABLE- ALARM ON BOTH PUMPS, CASSETTE LOT 4220003, EXPIRATION DATE 2026/11/24. NCSC RN ADVISED TO MIX NEW CASSETTE. PATIENT DECLINED TO REMAIN ON LINE WITH NURSE AND WILL CALL BACK IF ISSUES UNRESOLVED. PATIENT WASTED CASSETTE OF MEDICATION THAT WAS MIXED TODAY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801743 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4220003 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown