BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDEUCE PUMP TUBING W/CONNECTOR, 8' LONG

    MDR report key: 2780319 · Received October 10, 2012

    Report

    Report Number
    1220246-2012-00199
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K083707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS NOT CONFIRMED. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THE EVALUATION REVEALED THE BLADDER/SLEEVE INSIDE THE DRIP CHAMBER COLLAPSED. CUSTOMER'S PUMP WAS NOT RETURNED. THE RETURNED TUBING WAS TESTED WITH A NEW AR-6480 AT SET PRESSURES. THE PUMP COULD NOT REACH SET PRESSURES BUT GAVE A TIMEOUT "PRESSURE FAULT" ERROR MESSAGE. TYPICALLY, THIS TYPE OF EVENT IS CAUSED BY THE END USER DISCONNECTING AND RECONNECTING THE TUBING FROM THE PUMP. ON THE TUBING PACKAGE, THERE IS A LABEL INSTRUCTING THE USER AS FOLLOWS: "WARNING: DO NOT RECONNECT TUBING FOR ANY REASON. RECONNECTING TUBING THAT WAS DISCONNECTED MAY CAUSE PUMP PRESSURE MONITORING SYSTEM ERRORS WHICH MAY CAUSE EXTRAVASATION THAT COULD RESULT IN SERIOUS PATIENT INJURY." THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE MIDDLE OF THE CASE DURING THE KNEE SCOPE, THE PUMP MADE A SOUND AND STARTED SPINNING OUT OF CONTROL AND OVER PRESSURING. THE PUMP WAS SET AT 35 WHEN THIS OCCURRED. IT FILLED THE JOINT SO FAST THE CAPSULE BURST AND THE PATIENTS KNEE AND LEG BEGAN TO SWELL UP TO THE THIGH. THE SWELLING WENT DOWN AFTER IT WAS STOPPED AND THERE WAS NO EXTENDED STAY. HOWEVER, THE CASE WAS ABORTED AND THE DOCTOR CLOSED THE KNEE. THE CASE WILL BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDEUCE PUMP TUBING W/CONNECTOR, 8' LONG ARTHROSCOPE HRX ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-6480, DUALWAVE ARTHROSCOPY PUMP- NO SERIAL NO.