BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14515415 · Received May 26, 2022

    Report

    Report Number
    3012307300-2022-09688
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    March 30, 2022
    Report Date
    May 26, 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 THE PATIENT HAD A MALFUNCTIONING CASSETTE FROM LOT NUMBER 4192063. CHANGED THE CASSETTE AND GOT A -NO DISPOSABLE PUMP WON'T RUN- ALARM. SWITCHED THE CASSETTE TO THE BACK UP PUMP AND GOT THE SAME ALARM. THEN MIXED ANOTHER NEW CASSETTE AND WAS ABLE TO RESUME THE INFUSION WITH NO ISSUE. PATIENT DOES NOT HAVE THE CASSETTE TO RETURN FOR INVESTIGATION. AN ORDER FOR MORE CASSETTES WAS ALREADY SHIPPED AND WILL ARRIVE TO THE PATIENT TODAY. NO HARM WAS DONE TO THE PATIENT. THIS IS A LIFE-SUSTAINING INFUSION. NO FURTHER INFORMATION AVAILABLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803808 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4192063 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female