BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CWIII ARTHROSCOPY PUMP

    MDR report key: 8713446 · Received June 19, 2019

    Report

    Report Number
    1220246-2019-01156
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    March 18, 2019
    Report Date
    August 2, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867039346
    PMA / PMN Number
    K024291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT COULD NOT BE CONFIRMED. VISUAL EVALUATION REVEALED MINOR DAMAGE TO THE UNIT. DURING DEVICE FUNCTIONING THE RETURNED AR-6475 ARTHROSCOPY PUMP PASSED ALL BENCH TESTING BEFORE AND AFTER CONDUCTING A 4 HOUR BURN-IN VERIFICATION TEST.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS DISCOVERED VIA FACILITY MEDWATCH REPORT ((B)(4)) THAT THE FOLLOWING WAS REPORTED: "THE SURGEON HAS CONCERNS THAT THE ARTHREX PUMP THAT WAS USED IN THE SURGERY WAS NOT CALIBRATED TO DELIVER THE CORRECT AMOUNT OF FLUID, CAUSING SWELLING IN THE PATIENT'S QUADRICEPS MUSCLE. PREVENTATIVE & CORRECTIVE MAINTENANCE RECORDS WERE REVIEWED AS WELL AS THE MANUFACTURERS GUIDELINES OF USE. THE PUMP WAS USED AS DIRECTED. UPON RECEIVING THIS CONCERN, THE PUMP WAS TESTED AGAINST FACTORY SPECIFICATIONS WITH THE FOLLOWING RESULTS @ 10% FLOW: PRESSURE SET: 35, 50, 75, 100, 120. DISPLAY: 77, 110, 165, 220, 264. ACTUAL: 82, 116, 174, 229, 274. PER (FACILITY) BIOMED DEPARTMENT, THESE READINGS ARE WITHIN THE MANUFACTURER'S SPECIFICATIONS. THE PUMP HAS BEEN SEQUESTERED AND THE REMAINING PUMPS WILL BE EXCHANGED BY THE MANUFACTURER. PROCEDURE WAS A KNEE ARTHROSCOPY. ORIGINAL INTENDED PROCEDURE WAS A KNEE ARTHROSCOPY. THIS PATIENT REQUIRED A REPEAT KNEE ARTHROSCOPY FOR AN INFECTED JOINT." APPROXIMATE AGE OF DEVICE: 11 YEARS THIS SAME PUMP WAS ALSO USED IN TWO ADDITIONAL CASES WHICH HAVE BEEN REPORTED VIA FACILITY MEDWATCH REPORTS: MEDWATCH (B)(4) (ARTHREX REFERENCE: (B)(4)) AND MEDWATCH (B)(4) (ARTHREX REFERENCE: (B)(4)). ADDITIONAL INFORMATION OBTAINED 5/22/2019 FROM SALES REP: THE FACILITY PUMPS HAVE SINCE BEEN EXCHANGED DUE TO PUMP AGE AND THE EXCHANGED PUMPS WERE NO LONGER UNDER CONTRACT. ADDITIONAL INFORMATION OBTAINED 5/30/2019 FROM FACILITY: DATE OF PROCEDURE WAS (B)(6) 2019. PATIENT ISSUE DID NOT OCCUR DURING THE PROCEDURE. ON (B)(6) 2019 PATIENT WAS SEEN OUTPATIENT FOR LEFT THIGH HEMATOMA. THE SWELLING WAS REMOVED WITH AN ULTRASOUND GUIDED NEEDLE BIOPSY. PATIENT WAS BROUGHT INTO THE OR ON (B)(6) 2019 FOR A LEFT KNEE ARTHROSCOPIC WASHOUT AND THEN ADMITTED. PATIENT WAS DISCHARGED ON (B)(6) 2019. THE TUBING USED WITH THE PUMP WAS PART NUMBER AR-6410. THE PUMP WAS SEQUESTERED AFTER (B)(6) 2019. PATIENT WAS CONFIRMED TO HAVE STAPHYLOCOCCUS AUREUS WHICH WAS DISCOVERED ON (B)(6) 2019. TUBING DISPOSITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507961 CWIII ARTHROSCOPY PUMP ARTHROSCOPE HRX ARTHREX, INC. CWIII ARTHROSCOPY PUMP 00888867039346

    Patients

    Seq Age Sex Outcome Treatment
    1