BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q PUMP

    MDR report key: 2109813 · Received May 26, 2011

    Report

    Report Number
    2026095-2011-00152
    Event Type
    Death
    Date Received
    May 26, 2011
    Date of Event
    September 8, 2003
    Report Date
    May 2, 2011
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVAL AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFO 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." (B)(4). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (B)(4). IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DRUG/DILUENT: SENSORCAINE 0.5% + EPINEPHRINE. FILL VOLUME: 300CC AND FLOW RATE: UNK. PROCEDURE: SHOULDER SURGERY. CATHPLACE: SHOULDER JOINT. PT ALLEGEDLY DEVELOPED CHONDROLYSIS IN HIS SHOULDER AFTER PAIN PUMP USED FOLLOWING SHOULDER SURGERY ON (B)(6) 2003. HE DIED AS A RESULT OF AN OVERDOSE OF PAIN MEDICATION ON OR ABOUT (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP ELASTOMERIC PUMP MEB I-FLOW CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other