BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 2100697 · Received May 18, 2011

    Report

    Report Number
    2026095-2011-00144
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    December 27, 2004
    Report Date
    April 21, 2011
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RESULTS: THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFORMATION CONCERNING THE PROCEDURE, OR OTHER PARTICULARS OF THE ALLEGED INCIDENT. WITHOUT THE ACTUAL PRODUCT OR DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. THE ON-Q PUMP DIRECTIONS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1304265, REV.L). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, REV. 3). IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    (DRUG/DILUENT: MARCAINE 0.5%), (FILL VOLUME: 300ML & FLOW RATE: 5ML/HR), (PROCEDURE: ARTHROSCOPIC SHOULDER SURGERY), (CATHPLACE: RIGHT SHOULDER). PT ALLEGEDLY SUFFERED CARTILAGE DAMAGE IN HIS RIGHT SHOULDER FOLLOWING PLACEMENT OF AN ON-Q PAINBUSTER PUMP THAT CONTINUALLY INFUSED ANESTHETICS FOR APPROX 48 HOURS POSTOPERATIVELY ON (B)(6) 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER ELASTOMERIC PUMP MEB I-FLOW CORPORATION 5001363 482146

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other