BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUOUS WAVE III ARTHROSCOPY PUMP

    MDR report key: 3834442 · Received May 28, 2014

    Report

    Report Number
    1220246-2014-00083
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K024291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 REQUESTED/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT IS OR PROCEDURES RELATED TO THE SET-UP OF THE DEVICE AND TUBING DID NOT CONFORM TO INSTRUCTIONS PROVIDED OR BY THE END USER DISCONNECTING AND RECONNECTING THE TUBING FROM THE PUMP OR SPIKING THE SALINE BAGS IN THE INCORRECT ORDER. 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 INSTRUCTIONS FOR USE ARE NOT FOLLOWED. THE INSTRUCTIONS FOR USE FOR BOTH THE PUMP AND TUBING SETS CLEARLY WARN THE USER OF THE CONSEQUENCES OF NOT FOLLOWING THE INSTRUCTIONS FOR USE. 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 THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPECTED BUT NOT YET RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP STARTED TO RUN VERY FAST AND THE PATIENT HAD A VERY INFLATED KNEE. IT ONLY STOPPED WHEN ALL SALINE WAS GONE. PATIENT ENDED UP IN INTENSIVE CARE BUT WENT HOME SAME DAY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313876 CONTINUOUS WAVE III ARTHROSCOPY PUMP ARTHROSCOPE HRX ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other