BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP, CONTINUOUS WAVE III

    MDR report key: 1202760 · Received October 10, 2008

    Report

    Report Number
    1220246-2008-00213
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K024291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED; IT WAS REPORTED THAT THE HOSPITAL BIO-MED STAFF EVALUATED THE PUMP AFTER THE CASE AND CLEARED THE PUMP FOR FUTURE USE. THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED AND THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. REVIEW OF SIMILAR EVENTS REPORTED TO ARTHREX, WHERE PUMP AND TUBING WERE RETURNED FOR EVALUATION, INDICATE THAT OR PROCEDURES RELATED TO THE SET-UP OF THE DEVICE AND TUBING DID NOT CONFORM TO INSTRUCTIONS PROVIDED. THE LABELING FOR THE DEVICE AND ASSOCIATED TUBING, INSTRUCTION MANUAL FOR THE PUMP AND TROUBLESHOOTING GUIDE FOR THE DEVICE CLEARLY OUTLINE THE PROPER SET-UP PROCEDURE AND SUFFICIENTLY WARN THE USER OF THE POTENTIAL CONSEQUENCES (EXTRAVASATION) IF THE INSTRUCTIONS FOR USE ARE NOT FOLLOWED. A KEY POINT STRESSED IS THE IRRIGATION FLUID BAGS ARE NOT TO BE SPIKED UNTIL AFTER THE PRESSURE SENSOR LINE IS PLUGGED IN AND THE EMPTY TUBING IS LOADED AROUND THE PUMP ROLLERS. ALSO, IF THE TUBING IS DISCONNECTED FOR ANY REASON, THE SAME TUBING SHOULD NOT BE RECONNECTED; A NEW TUBING SET SHOULD BE USED. IN ADDITION TO EQUIPMENT SET-UP, THE OPERATIVE JOINT CAPSULE MAY HAVE ALREADY BEEN COMPROMISED FROM PRIOR (PREOPERATIVE) INJURY OR TRAUMA. INCORRECT PRESSURE SETTINGS AND INTER-OPERATIVE COMPROMISING OF THE JOINT CAPSULE COULD ALSO LEAD TO SUCH AN EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP ROLLER WHEELS SPUN IN NORMAL FASHION WHEN THE SCOPE WAS INITIALLY PLACED INTO THE KNEE JOINT AND THE FLUID STOP COCK WAS OPENED. HOWEVER, IMMEDIATELY THE SURGEON NOTICED A SWELLING IN THE SURROUNDING TISSUES AND STOPPED SALINE FLOW. THE SWELLING DECREASED. INFLOW WAS RESUMED BUT AGAIN THERE WAS A RE-SWELLING OF THE TISSUES. THE SURGEON ELECTED TO CANCEL FURTHER ARTHROSCOPY TO REDUCE ANY POTENTIAL PATIENT INJURY. FOLLOW-UP WITH THE REPORTER PROVIDED INFORMATION THAT NO ALARMS SOUNDED ON THE PUMP. PUMP SETTINGS WERE 60MM/100FLOW, FLUID IN THE CHAMBER WAS NORMAL, AND THE ORANGE CLIP ON THE TUBING SENSOR WAS REMOVED PRIOR TO THE SALINE BAGS BEING SPIKED. THE TUBING WAS REPORTED AS DISCARDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR IN RESPONSE TO FOLLOW-UP COMMUNICATION. 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 PUMP, CONTINUOUS WAVE III HRX ARTHREX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other INFORMATION REQUESTED BUT NOT PROVIDED.