BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTES

    MDR report key: 13994766 · Received April 4, 2022

    Report

    Report Number
    3012307300-2022-05773
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    January 27, 2022
    Report Date
    April 4, 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

    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. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CADD CASSETTE HAD BOTH PUMP ALARMING NO DISPOSABLE AFTER INFUSED FOR 12 HOURS. LOT NUMBER 4192065. TROUBLESHOOTING SUCCESSFUL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620559 CADD MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4192065 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown