BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-SPIKE DISPOSABLE SET (1 PIECE)

    MDR report key: 21832237 · Received April 11, 2025

    Report

    Report Number
    1219702-2025-00023
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Report Date
    April 11, 2025
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTERNAL COMPLAINT FILE (B)(4) HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. THE DISPOSABLE INVOLVED IN THIS INCIDENT WAS NOT RETURNED TO BELMONT FOR INVESTIGATION. THE INCIDENT WAS INITIALLY REPORTED TO BELMONT BY THE USER FACILITY ON JAN 8TH, 2025 ABOUT THIS INCIDENT THAT THERE WAS NO PATIENT INVOLVED. BELMONT DOCUMENTED THE INCIDENT TO BE NON-REPORTABLE AT THAT POINT. SUBSEQUENTLY, BELMONT RECEIVED MEDSUN REPORT (B)(4) ON MARCH 13TH, 2025, WHICH PER OUR PROCEDURE REQUIRES US TO SUBMIT A REPORT. THE USER WILL LOSE THE ABILITY TO INFUSE THE PATIENT WITH THE AFFECTED SPIKES. OTHER SPIKES CAN BE USED TO INFUSE THE PATIENT AND THE DISPOSABLE SET CAN BE EXCHANGED TO CONTINUE INFUSION. THE OPERATOR'S MANUAL PROVIDES INSTRUCTIONS ON INSTALLING THE DISPOSABLE SET AND ADDITIONAL RECOMMENDED OPERATOR ACTIONS. THE USER IS INSTRUCTED TO "PRIME THE MAIN SYSTEM WITH SOLUTIONS COMPATIBLE WITH BLOOD PRODUCTS" PRIOR TO USE. ANY LEAK FROM A CONNECTOR WOULD BE NOTICEABLE PRIOR TO USE WITH A PATIENT. THE ISSUE OCCURRED DURING SET UP, PRIOR TO PATIENT INVOLVEMENT. BELMONT ISSUED RECALL # 1219702-01/02/2025-001 ASSOCIATED WITH THIS ISSUE, LIMITED TO SPECIFIC LOTS. THE CRACKED QUICK CONNECT WAS CONFIRMED VIA THE IMAGE SENT BY THE SITE. THE ROOT CAUSE WAS DETERMINED TO BE DUE A CHANGE FROM THE USE OF CYCLOHEXANONE TO ALCOHOL AND THAT EXPOSURE TO ALCOHOL VAPORS CAN CRACK THE CPC CONNECTOR. WE HAVE STOPPED USING ALCOHOL AND REVERTED BACK TO THE USE OF CYCLOHEXANONE ON THE FEMALE CONNECTOR TO RESOLVE THE ISSUE. WE WILL CONTINUE TO MONITOR THESE INCIDENTS GOING FORWARD.

    Description of Event or Problem · 0

    THE BIOMED REPORTED THAT, "TONIGHT WE HAD ISSUES WHEN ATTEMPTING TO SET UP THE BELMONT. THE TUBING HAS A LEAK AS SEEN IN THE TWO ATTACHED IMAGES. IN TOTAL WE ATTEMPTED TO CONNECT FIVE DIFFERENT TUBING KITS, ALL WITH THE SAME ISSUE. WE TRIED FROM BOTH LOT NUMBERS AVAILABLE IN STOCK AND BOTH HAD THE EXACT SAME ISSUE. THE LOT NUMBERS ARE: 20241002 AND 20241006. WE GATHERED THE ED STOCK FOR EXCHANGE WHEN AVAILABLE. HOLLEY WAS MADE AWARE OF THE ISSUE AND REACHED OUT TO LOGISTICS AS WELL. PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS TO HELP SOLVE THE PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091410 3-SPIKE DISPOSABLE SET (1 PIECE) WARMER, THERMAL, INFUSION FLUID LGZ BELMONT MEDICAL TECHNOLOGIES 903-00006P 20241002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown