BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET WITH FLOW STOP

    MDR report key: 14623837 · Received June 7, 2022

    Report

    Report Number
    3012307300-2022-10989
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 7, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE CASSETTE, CADD RESERVOIR CASSETTE DISPLAYED A "NO DISPOSABLE, PUMP WON'T RUN" ALARM. THE CUSTOMER CHANGED THE PUMP TO ANOTHER ONE, BUT THE ALARM PERSISTED. SO HE CHANGED THE CASSETTE TO ANOTHER ONE, AND NO ALARM SOUNDED. THE PUMPS USED TOGETHER WITH THE CASSETTES WERE 21-6500-09. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321495 CADD ADMINISTRATION SET WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4114183 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female