BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTINUOUS WAVE II ARTHROSCOPY PUMP

    MDR report key: 1340339 · Received March 10, 2009

    Report

    Report Number
    1220246-2009-00020
    Event Type
    Other
    Date Received
    March 10, 2009
    Date of Event
    February 4, 2009
    Report Date
    February 11, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K915721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED FOR EVALUATION; THE MAIN TUBING SET WAS NOT RETURNED. THE COMPLAINT WAS NOT CONFIRMED. VISUAL INSPECTION OF THE PUMP REVEALED PHYSICAL DAMAGE (SCRAPES) AND MINOR CORNER DENTS ON THE PUMP CASE. IT WAS ALSO OBSERVED THAT BOTH WARRANTY SEALS ON THE PUMP HAD BEEN BROKEN, MEANING THE PUMP MAY HAVE BEEN OPENED AND UNAUTHORIZED REPAIRS MAY HAVE OCCURRED WITHOUT ARTHREX'S KNOWLEDGE. THE MANUFACTURER'S EVALUATION REVEALED NO ISSUES THAT COULD HAVE CAUSED COMPARTMENT SYNDROME. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON INFO PROVIDED, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS IMPROPER PUMP/TUBING SETUP. REVIEW OF SIMILAR INCIDENTS REPORTED TO ARTHREX INDICATE THAT OR PROCEDURES RELATED TO THE SET UP OF THE DEVICE AND ASSOCIATED TUBING DID NOT CONFORM TO INSTRUCTIONS PROVIDED WITH THE DEVICE AND ASSOCIATED TUBING SET. WHEN A PUMP DOES NOT ALARM, THE CAUSE IS TYPICALLY EITHER THE END USER REPEATEDLY UNPLUGGING AND PLUGGING BACK IN THE TUBING OR SPIKING THE SALINE BAGS IN INCORRECT ORDER DURING PUMP SET-UP, CAUSING THE TUBING BLADDER TO COLLAPSE. THE INSTRUCTIONS FOR USE FOR BOTH THE PUMP AND THE TUBING SETS CLEARLY WARN THE USER OF THE CONSEQUENCES OF NOT FOLLOWING THE INSTRUCTIONS FOR USE. THE LABELING FOR THE DEVICE AND THE ASSOCIATED TUBING, THE INSTRUCTION MANUAL FOR THE PUMP AND A TROUBLESHOOTING GUIDE FOR THE DEVICE PROVIDED WITH EACH DEVICE AND TUBING SET, CLEARLY OUTLINES THE PROPER SET UP PROCEDURE AND SUFFICIENTLY WARNS THE USER OF THE POTENTIAL CONSEQUENCES IF THE DIRECTIONS ARE NOT FOLLOWED. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE PT EXPERIENCED COMPARTMENT SYNDROME. DURING THE CASE THE PUMP BEGAN TO SHUT OFF AND WAS RESTARTED 4 TO 5 TIMES. THE SURGEON NOTICED THE PT'S THIGH WAS TIGHT AND FIRM. THE DEVICE DID NOT ALARM AND THE TUBING WAS REPLACED WITH NO CHANGE. THE PROCEDURE WAS ABORTED. F/U WITH THE REPORTER PROVIDED INFO THAT DURING THE INITIAL SURGERY ON (B)(6) 2009 THE PUMP SETTING WAS AT 50 AND THE TUBING CHAMBER WAS 3/4 FULL. THE BLADDER INSIDE THE CHAMBER COLLAPSED. THE PRESSURE SENSOR WAS DISCONNECTED/RECONNECTED AND THE TUBING WAS CHANGED. THE DEVICE BEEPED THEN THE PUMP SHUT OFF. ADDITIONAL F/U REGARDING CURRENT PT CONDITION PROVIDED INFO THAT ON (B)(6) 2009 THE PT RECEIVED THE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THAT HAD BEEN ABORTED ON (B)(6) 2009. THE FACILITY USED A BACK UP AR-6400 AND THE SURGERY WAS SUCCESSFUL. IT WAS REPORTED THAT THE PT IS CURRENTLY DOING WELL. NO FURTHER PT INFO WAS PROVIDED. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS WAVE II ARTHROSCOPY PUMP HRX ARTHREX, INC. NA 4604

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention INFO REQUESTED BUT NOT PROVIDED