BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE PIECE MAIN PUMP&PATIENT EXT TBG

    MDR report key: 23404416 · Received October 28, 2025

    Report

    Report Number
    1220246-2025-04850
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867039131
    PMA / PMN Number
    K083707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS NOT CONFIRMED. DUE TO DEVICE CONTAMINATION, ONLY A VISUAL EVALUATION WAS PERFORMED. THE REPORTED ISSUE¿THAT THE TUBING CONNECTED TO THE PUMP WAS LEAKING¿COULD NOT BE VERIFIED, AS PUNCTURES OR LEAKS WERE NOT VISIBLE IN THE PHOTOGRAPHIC EVIDENCE PROVIDED FOR DEVICE AR-6415, BATCH NUMBER: N5026. THE EXTERIOR OF THE TUBING APPEARED INTACT, AND NO ABNORMALITIES WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION¿WHICH MAY INCLUDE THE RETURNED DEVICE (IF APPLICABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA¿ARTHREX DETERMINED THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE. THE MOST LIKELY ROOT CAUSE MAY BE ATTRIBUTED TO MISUSE OR MISHANDLING OF THE DEVICE, POTENTIALLY DUE TO ENVIRONMENTAL OR HANDLING FACTORS LEADING TO TUBING RUPTURE OR IMPROPER INSTALLATION OR CONNECTION OF THE TUBING. PER DFU INFORMATION ¿ AR-6415 TUBING SETUP AND CONFIGURATION: THE AR-6415 TUBING IS PART OF THE ONE-PIECE TUBING CONFIGURATION USED WITH THE ARTHREX DUALWAVE PUMP (AR-6480). IT INCLUDES MAIN PUMP TUBING AND PATIENT EXTENSION TUBING, DESIGNED FOR SINGLE-USE UNDER STERILE CONDITIONS. WARNINGS AND PRECAUTIONS: ENSURE PROPER INSTALLATION OF TUBING INTO THE ROLLER PUMP TO AVOID PINCHING, MISALIGNMENT, OR DAMAGE. DO NOT REUSE TUBING¿REUSE MAY COMPROMISE INTEGRITY AND LEAD TO LEAKS. INSPECT TUBING FOR DAMAGE PRIOR TO USE. ANY VISIBLE WEAR, KINKS, OR CRACKS SHOULD RESULT IN IMMEDIATE REPLACEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THERE WAS A LEAK DETECTED IN THE PIPE INSIDE THE ROLLER PUMP. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 09-OCT-2025 AVOE IT WAS CONFIRMED THAT THE ARTHREX PUMP AR-6480 WAS USED WITH THE INITIALLY REPORTED TUBING. THE SN OF THE DEVICE IS (B)(6), SINCE THE CUSTOMER HAS TWO PUMPS AND THEIR USE IS NOT TRACKED. THIS IS THE FIRST TIME SUCH AN INCIDENT HAS OCCURRED, EVEN THOUGH IT IS A DEVICE THAT IS USED VERY OFTEN. THE PROBLEM OCCURRED AS SOON AS IT WAS CONNECTED. NO SIMILAR INCIDENTS SINCE. UPDATE AVOE 09-OCT-2025 AVOE A USER REPORT WAS PROVIDED BY THE AUTHORITY FOR THIS CASE. THERE WAS A SIGNIFICANT WATER LEAKAGE FROM THE ARTHROPUMP SYSTEM. THE LEAK WAS DETECTED IN THE TUBING INSIDE THE ROLLER PUMP. VIDEO COLUMN DISPLAYED ¿FLOODED,¿ REQUIRING EMERGENCY SHUTDOWN DUE TO ELECTRICAL HAZARDS AS ALL POWER CABLES WERE SUBMERGED IN SALINE SOLUTION. THE PATIENT WAS NOT AFFECTED, BUT AN EMERGENCY SHUTDOWN AND THE DISCONNECTION OF THE ARTHROSCOPY COLUMN'S ELECTRICAL SYSTEM WAS REQUIRED FOLLOWING A DRYING OF EACH MODULE OF THE COLUMN AND ITS POWER CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139984 ONE PIECE MAIN PUMP&PATIENT EXT TBG ARTHROSCOPE AND ACCESSORIES HRX ARTHREX, INC. ONE PIECE MAIN PUMP&PATIENT EXT TBG N5026 00888867039131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown