BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DW ARTHROSCOPY FLUID MANAGEMENT DEV

    MDR report key: 20189295 · Received September 11, 2024

    Report

    Report Number
    1220246-2024-07507
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 22, 2024
    Report Date
    November 11, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867039377
    PMA / PMN Number
    K083707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    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: D9, G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. ONE UNPACKAGED AR-6480 ARTHROSCOPY PUMP SERIAL NUMBER: (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED NO PROBLEMS WITH THE RETURNED DEVICE. THE RETURNED AR-6480 ARTHROSCOPY PUMP WAS ASSEMBLED WITH AN AR-6410 LOT NUMBER: 63988853, AND AN AR-6430 LOT NUMBER: 130049 PUMP TUBING AND WAS TESTED AND EVALUATED UNDER NORMAL CONDITIONS TO SEE IF THE FAILURE COULD BE REPRODUCED. THE PUMP WAS CONNECTED TO THE POWER AND TURNED ON. AFTER SELECTING THE DESIRED PRESSURE, THE RUN BUTTON WAS PRESSED TO START THE MACHINE. THE PUMP WAS RUN FOR 65 MINUTES WITH NO ISSUES. NO SUDDEN CHANGES IN PRESSURE WERE NOTED. NO PROBLEM FOUND. PRESSURE FAULT TEST: WHEN THE PRESSURE WAS ARTIFICIALLY LOWERED BY REMOVING THE INLET FROM THE FLUID SOURCE, AN ALARM WAS TRIGGERED, AND THE DEVICE STOPPED. THIS BEHAVIOR IS EXPECTED¿NO PROBLEM FOUND. A CLAMPING TEST WAS PERFORMED AS DEFINED IN THE USER GUIDE (DFU-0212 REV 1 ¿ SECTION 5.2) TO SIMULATE AN OVERPRESSURE FAILURE ON THE PUMP AND TO VERIFY IF AN ERROR MESSAGE AND/OR AUDIBLE ALARM WOULD BE TRIGGERED. THE RESULTS OF THE CLAMP TEST INDICATE THAT THE PUMP TRIGGERED AN ALARM, AND THE ROLLERS DID STOP MOVING. THIS BEHAVIOR IS EXPECTED¿NO PROBLEM FOUND. PRESSURE TESTING EVALUATION WITH THE PRESSURE CALIBRATOR SET AT 100 AND 200 MMHG GAVE THE PUMP PRESSURE RESULTS OF 46 AND 91, RESPECTIVELY. THESE RESULTS INDICATED NO PROBLEM WITH PRESSURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THERE WAS A LOSS OF PRESSURE WITH THE DEVICE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555563 DW ARTHROSCOPY FLUID MANAGEMENT DEV ARTHROSCOPE AND ACCESSORIES HRX ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV 00888867039377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown