BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD 50ML/100ML MEDICATION CASSETTE RESERVOIRS WIT

    MDR report key: 13281807 · Received January 18, 2022

    Report

    Report Number
    3012307300-2022-00975
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Report Date
    January 18, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION TO DETECT SAMPLE CONDITIONS THAT COULD CAUSE FUNCTIONAL ISSUES. RESULTS: THE SAMPLE WAS RECEIVED IN DAMAGED CONDITIONS WITH SPRING AND ARM OCCLUSION DISASSEMBLED. OTHER ANALYSIS: FUNCTIONAL TESTING: SAMPLE WAS FILLED WITH 100 ML OF WATER; THE SAMPLE WAS CONNECTED TO THE CADD LEGACY PLUS TO LOOK FOR UNUSUAL FUNCTION. SAMPLE WAS ASSEMBLED AGAIN WITH THE SPRING AND ARM OCCLUSION TO PERFORM THE TEST. RESULTS: SAMPLE WAS FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTY. THE PUMP WAS SET RUNNING AND NO ALARMS WERE ACTIVATED. THE COMPLAINT IS NOT CONFIRMED. ROOT CAUSE: THE COMPLAINT WAS NOT CONFIRMED DUE TO SAMPLE WAS TESTED AND NO ALARMS WERE ACTIVATED. ACTIONS TAKEN: NO ACTIONS TAKEN WERE PERFORMED SINCE THE COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE APPEARS TO BE A CONNECTION ERROR BETWEEN THE CASSETTE AND THE CADD PUMP. MOVEMENT OF THE PUMP AND/OR PATIENT COULD CREATE MORE SPACE, CAUSING THE LOCK TO LOOSEN AND THUS CREATING A 'DISPOSABLE SET'. CONNECTING ANOTHER CADD PUMP WAS NOT THE SOLUTION. THE CADD PUMP CONTINUED TO DISPLAY THE DISPOSABLE MESSAGE. REPLACING THE IV LINES TO THE CADD ALSO DID NOT STOP THE MESSAGE BEFORE A PATIENT LEAVES, THE HRH WILL MAKE AN EXTRA CHECK TO ENSURE THAT THE LOCK IS COMPLETELY VERTICAL AND THAT THE CASSETTE AND CADD PUMP ARE PROPERLY CONNECTED TO EACH OTHER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203926 CADD 50ML/100ML MEDICATION CASSETTE RESERVOIRS WIT SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4084910 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown