BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J011RO JOEY ADAPUTER TYPE X30

    MDR report key: 12866486 · Received November 23, 2021

    Report

    Report Number
    8040459-2021-00569
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    November 10, 2021
    Report Date
    January 5, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION WITHOUT PACKAGE. THE SAMPLE CONSISTED OF PRODUCT CODE J011RO WITH AN UNKNOWN LOT NUMBER. THE SAMPLE WAS EVALUATED BY VISUAL INSPECTION UNDER MICRO ZOOM AND PUMP TESTER. THE RESULT WAS FORMULA LEAKING FROM A PIN HOLE ON THE SILICONE TUBE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED SINCE A LOT NUMBER WAS NOT REPORTED. HOWEVER, ALL RECORDS FROM MANUFACTURING LOTS ARE REVIEWED AND CONFIRMED THAT PRODUCTS WERE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. PER THE SUPPLIER¿S FINITE ELEMENT ANALYSIS (FEA) CONDUCTED ON PREVIOUS INVESTIGATIONS WAS FOCUSED ON THE CENTER SIX CAVITIES. FROM THIS SIMULATION RESULTS WE LEARNED THAT THE MATERIAL FILLED FASTER IN THE CENTER CAVITIES COMPARED TO THE REST, THIS CREATES A BACKFILL CONDITION WHERE THE MATERIAL FLOWS INTO THE OTHER TUBES, WHICH ARE FILLING SLOWER. A NEW MOLD-FLOW ANALYSIS WAS CONDUCTED ON THE CURRENT TOOL USED TO PRODUCE THE MATERIAL TO UNDERSTAND ITS CURRENT STATE. AS A RESULT OF THIS STUDY IT WAS CONFIRMED THAT AIR BUBBLES WERE CAUSED BY THE ¿BACKFLOW¿ EFFECT. THE BACKFLOW IS A FUNCTION OF THE TOOL DESIGN. FOLLOWING THIS RESULT, TOOLING MODIFICATIONS WERE DEVELOPED AND AN FEA SIMULATION WAS COMPLETED, INCLUDING ANALYZATION OF THE MODIFICATIONS¿ IMPACT ON THE BACKFLOW CONDITION. BASED ON SUPPLIER INVESTIGATION THE ROOT CAUSE IS DUE TO MATERIAL ISSUE (PUMPING SECTION) TOOL DESIGN. THE AIR BUBBLES IN THE SILICONE TUBING ARE CAUSED BY THE ¿BACKFLOW¿ DURING MACHINE OPERATION CAUSING SILICONE TUBE DAMAGE AND FORMULA LEAKAGE DURING CUSTOMER USING. AS A CORRECTIVE ACTION THE ROUTER INSTRUCTIONS WERE UPDATED AND TRAINING WAS COMPLETED AS PART OF A QUALITY ALERT TO INDICATE THE INSPECTION OF PARTS FOR BUBBLES. AS A PREVENTATIVE ACTION VALIDATION OF NEW PLATES AND TOOLS FOR THE MOLDING PROCESS OF THE JOEY TUBE HAVE BEEN SUCCESSFULLY COMPLETED. THREE RUNS WERE MOLDED OVER THREE SHIFTS. THIRTY SHOTS WERE COLLECTED PER RUN AND MEASURED FOR CRITICAL CHARACTERISTICS ON ELEVEN (11) CAVITIES DETERMINED TO HAVE THE HIGHEST STANDARD DEVIATION DURING THE OQ STUDY. ALL DIMENSIONAL RESULTS SHOW CAPABILITY AS ACCEPTABLE. AT THIS TIME, NO FURTHER ACTIONS ARE NEEDED. THIS COMPLAINT WILL BE USED OR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHILE FORMULA WAS BEING FED, A LEAK FROM THE TUBE WAS FOUND. SINCE AIR BUBBLES WERE OBSERVED IN THE TUBE, A HOSPITAL PERSONNEL CHECKED THE PUMP AND PUMP SET, AND SUCH LEAK WAS NOTICED. NO PATIENT HARM. THE DURATION OF USE AND TYPE OF FORMULA USED IS UNKNOWN. THE DEVICE WAS BEING USED WITH A PATIENT WITH DIARRHEA. ON THE REPORTER STATED THERE WAS AIR IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763343 J011RO JOEY ADAPUTER TYPE X30 PUMP, INFUSION, ENTERAL LZH CARDINAL HEALTH J011RO

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown