BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10149989 · Received June 12, 2020

    Report

    Report Number
    3012307300-2020-05855
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Date of Event
    April 1, 2020
    Report Date
    August 10, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027536
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: RETURNED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION BUT THE ARCH HEIGHT PUMP TUBE IS LOW. THE RETURNED SAMPLES FAILED ACCURACY TESTING CONFIRMING THE INITIAL FAILURE. TESTING / INSPECTION: A REVIEW OF THE MANUFACTURING PROCESS FOR P/N: 21-7394-24, L/N: 4012767 WAS CONDUCTED BY QUALITY ENGINEER ON 7-JUL-2020, IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT AS DESCRIBED IN? COMPLAINT DESCRIPTION? SECTION. OTHER ANALYSIS: DURING THE MANUFACTURING PROCESS, PRODUCTION PERSONNEL DO A VISUAL INSPECTION BEFORE A PROCESS (ASSEMBLE, BOND, ETC.) TO ENSURE THAT THE MATERIAL IS IN PERFECT SHAPE; ALSO, RIGHT AFTER A WORK STATION, PERSONNEL REDO AN INSPECTION IN ORDER TO FIND ANY DISCREPANCIES. PRODUCTION PERSONNEL PERFORM A 100% VISUAL INSPECTION IN ORDER TO VERIFY THAT THE PUMP TUBE ARCH HEIGHT IS WITHIN TOLERANCE. PRODUCTION PERSONNEL PERFORM AN ACCURACY TEST TO 4 SAMPLES AT SHIFT START UP, THE END OF EVERY SHIFT, THE BEGINNING OF EVERY JOB, THE END OF EVERY JOB; OR A NEW LOT OF MATERIALS / COMPONENTS OR EQUIPMENT ADJUSTED. QUALITY TAKES A SAMPLE OF 15 UNITS AT AN INTERVAL OF TWO (2) HOURS, PRIOR TO PLACING PRODUCT IN BAG, IN ORDER TO: INSPECT PUMP TUBE UV BOND TO HOUSING, IN ORDER TO VERIFY THAT THE PUMP TUBE ARCH HEIGHT IS WITHIN TOLERANCE. VERIFY THAT THE ADHESIVE NOT BE EXCESSIVE OR OUTSIDE THE DEFINED APPLICATION AREA. VERIFY PARTS ARE FREE OF DAMAGE (SCUFFS, PINCH MARKS, ETC.), CRACKS, CRAZING, CUTS, OR OTHER WORKMANSHIP DEFECTS THAT CAN AFFECT ASSEMBLY FUNCTION OR APPEARANCE. AUDIT THE ACCURACY TEST IS BEING PERFORMED ACCORDING TO THE MANUFACTURING PROCEDURE. ROOT CAUSE: IN ORDER TO PERFORM A COMPLETE ROOT CAUSE ANALYSIS OF THIS FAILURE MODE, CAPA: 20CAPA018 WAS OPEN ON 15-OCT-2019. ACTION TAKEN: CAPA: 20CAPA018 WAS OPEN ON 15-OCT-2019 IN ORDER TO IMPLEMENT CORRECTIVE ACTIONS FOR THIS FAILURE MODE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT WHILE USING CADD ADMINISTRATION SETS - FLOW STOP AN INTERNAL VOLUME CHECK WAS PERFORMED AND AN UNDER-DELIVERY VARIANCE OF 8% - 15% WAS NOTED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613167 CADD FPA ST PAUL 21-7394-24 3925422 10610586027536

    Patients

    Seq Age Sex Outcome Treatment
    1