BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE PIECE MAIN PUMP&PATIENT EXT TBG

    MDR report key: 21838860 · Received April 15, 2025

    Report

    Report Number
    1220246-2025-01422
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 24, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K083707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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

    B5, D1, D4, G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE DEVICE WAS DISCARDED IN THE FACILITY PER EVENT DESCRIPTION. THE MOST LIKELY CAUSE IS USER ERROR DUE TO DISCONNECTING/RECONNECTING TUBING WHICH MAY RESULT IN PUMP PRESSURE ERRORS. TO SUPPORT THE MLC RESULTS, THE NEW/SEALED DEVICE RETURNED WAS OPENED AND TESTED. THE TUBING DID NOT HAVE ANY VISUAL ISSUES. FUNCTIONAL TESTING: THE RETURNED DEVICE AR-6415 WAS ASSEMBLED WITH THE KNOWN-GOOD PUMP AR-6480, AND IT WAS TESTED AND EVALUATED UNDER NORMAL CONDITIONS TO SEE IF THE FAILURE COULD BE REPRODUCED. NO PROBLEM WAS FOUND WITH THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KAS SURGERY THE PUMP COULD NOT MAINTAIN THE PRESSURE AND THE PRESSURE HAS RISEN MASSIVELY. THE PATIENT`S THIGH GOT SWOLLEN ABOVE THE BLOOD BARRIER. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. ACCORDING TO THE PROVIDED INFORMATION A SECOND SURGERY WAS REQUIRED. UPDATE AVOE 31-MAR-2025: IT WAS CONFIRMED THAT THE TUBING AR-6430 (LOT: 409041) WAS USED WITH THE REPORTED PUMP. IT WAS FURTHER REPORTED THAT THE PUMP CONTINUED TO PUMP EVEN THOUGH FLUID WAS ALREADY FLOODED INTO THE PATIENT. PRESSURE MEASUREMENT DID NOT STOP THE IRRIGATION. THE PATIENT HAS SUFFERED AN INTRAOPERATIVE COMPARTMENT SYNDROME. THE SAME DEVICE WAS USED TO FINISH THE SURGERY. DESPITE COMPARTMENT SYNDROME AND PROCEDURAL DELAY, THE SURGERY WAS FINISHED SUCCESSFULLY. UPDATE AVOE 14-APR-2025: IT WAS CONFIRMED THAT THE COMPARTMENT SYNDROME WAS TREATED BY OPENING THE BLOOD BARRIER.

    Description of Event or Problem · 0

    UPDATE AVOE 26-MAY-2025: ACCORDING TO THE SALES REP. THE REPORTED TUBING AR-6430 (LOT: 409041) WAS INCORRECT AND THE AFFECTED DEVICE WAS THE AR-6415 (LOT: N4042). THE USED TUBING WAS DISCARDED, BUT THE LAST UNUSED TUBING FROM THE SAME LOT WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115311 ONE PIECE MAIN PUMP&PATIENT EXT TBG ARTHROSCOPE AND ACCESSORIES HRX ARTHREX, INC. AR-6415 N4042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other