BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 10399133 · Received August 12, 2020

    Report

    Report Number
    3012307300-2020-08129
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Report Date
    October 22, 2020
    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

    FOUR CADD CASSETTE RESERVOIRS - FLOW STOP WERE RETURNED FOR ANALYSIS. THE SAMPLE WAS VISUALLY INSPECTED, AT A DISTANCE OF 12" TO 24" AND NORMAL CONDITIONS OF ILLUMINATION. NO DISCREPANCIES WERE FOUND. THE SAMPLE WAS CONNECTED TO THE CADD LEGACY PLUS TO LOOK FOR UNUSUAL FUNCTION; NO DISCREPANCIES WERE DETECTED; THE ACCURACY TEST WAS SUCCESSFULLY PASSED. THE SAMPLE WAS FULLY PRIMING AND CONNECTED WITHOUT DIFFICULT, THE PUMP WAS SET RUNNING AND THE ALARM WAS NOT ACTIVATED. THE COMPLAINT WAS NOT CONFIRMED. THE CURRENT PROCESS CONTROL AND THE RISK MANAGEMENT PLAN FOR CASSETTE RESERVOIR WERE REVIEWED. THESE ARE THE CURRENT MITIGATIONS ESTABLISHED IN PROCESS RELATED WITH THE DELIVERY ISSUE: PRODUCTION PERFORMS A 100 PERCENT IN PROCESS INSPECTION, IN ORDER TO VERIFY FOR OCCLUSIONS, KINKED TUBING VERIFY THAT THE BAG IS PROPERLY PLACED AND VERIFIES THAT THE HEIGHT OF THE ARCH OF THE PUMP TUBE IS WITHIN SPECIFICATION. PRODUCTION PERFORMS AN ACCURACY TEST; TAKES A SAMPLE OF THREE PARTS AT SHIFT START-UP, BEGINNING OF EVERY JOB; AT LEAST EVERY FIVE HOURS. QUALITY TAKES A SAMPLE OF 15 UNITS AT AN INTERVAL OF TWO HOURS PLUS OR MINUS 30 MINUTES, PRIOR TO PLACING THE PRODUCT IN THE BAG, IN ORDER TO VERIFY FOR OCCLUSIONS, KINKED TUBING AND VERIFY THAT THE BAG IS PROPERLY PLACED AND VERIFIES THAT THE HEIGHT OF THE ARCH OF THE PUMP TUBE IS WITHIN SPECIFICATION. A ROOT CAUSE CANNOT BE DETERMINED SINCE THE COMPLAINT WAS NOT CONFIRMED DUE TO THE FACT THE ACCURACY TEST WAS SUCCESSFULLY PASSED. DEVICE HISTORY RECORD: PART NUMBER = 21-7302-24, LOT NUMBER= 3922201, MANUFACTURING DATE = JAN 20 2020, QUANTITY = 15552 UNITS, NCRS, DMRS, ETS, DAS = NONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT FOR INFUSION. THE REPORTER STATED THE DISPLAYED REMAINING INFUSION VOLUME ON THE PUMP DID NOT MATCH THE ACTUAL REMAINING VOLUME OF MEDICATION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861567 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 3922201 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1