BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q PAINBUSTER, SILVERSOAKER

    MDR report key: 2379064 · Received December 13, 2011

    Report

    Report Number
    2026095-2011-00427
    Event Type
    Death
    Date Received
    December 13, 2011
    Date of Event
    March 20, 2011
    Report Date
    November 18, 2011
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSION: A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: LIDOCAINE 2%. FILL VOLUME: UNKNOWN. FLOW RATE: 5ML. PROCEDURE: SHOULDER SURGERY. CATHPLACE: SHOULDER. A (B)(4) REPRESENTATIVE REPORTED THE DEATH OF A PATIENT USING AN I-FLOW PUMP FOLLOWING SHOULDER SURGERY. SURGERY WAS PERFORMED ON (B)(6) 2011. A CATHETER WAS PLACED IN THE JOINT AND WAS CONNECTED TO AN ON-Q PAINBUSTER. THE PUMP WAS FILLED WITH 2% LIDOCAINE. THE PATIENT'S PARENTS REPORTED THAT SHE HAD BEEN CONFUSED, DELIRIOUS, AND HAD COMPLAINED OF NAUSEA. THE PARENTS CLAIM SHE ALSO HAD A SEIZURE. ON (B)(6) 2011, THE PATIENT WAS FOUND DECEASED AT APPROXIMATELY 0600 HOURS AT HOME. RESUSCITATION ATTEMPTS WERE NOT SUCCESSFUL. A POST-MORTEM EXAMINATION BY A MEDICAL EXAMINER (ME) FOUND A BLOOD LEVEL OF LIDOCAINE OF 6.4 MCG/ML./ THE ME CONCLUDED THAT THE CAUSE OF DEATH WAS DUE TO LIDOCAINE TOXICITY. THE MEDICAL EXAMINER REPORTED THAT THE PATIENT HAD A HISTORY OF DIABETES. LIVER AND KIDNEYS WERE REPORTED AS NORMAL DURING THE POST-MORTEM EXAMINATION. THE MEDICAL EXAMINER NOTED THERE WAS NO OTHER MEDICAL HISTORY THAT WOULD HAVE CONTRIBUTED TO THE DEATH. THERE WERE NO OTHER MEDICATIONS FOUND IN THE PATIENT'S SYSTEM THAT WOULD HAVE CONTRIBUTED TO LIDOCAINE TOXICITY. PER DFU: NOMINAL FLOW RATE: 5ML/HR. NOMINAL FILL VOLUME: 270ML. THE INFUSION DELIVERY TIME IS 54 HOURS (2.25 DAYS) WHEN FILLED TO NOMINAL VOLUME AND FLOW RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER, SILVERSOAKER ELASTOMERIC PUMP MEB I-FLOW, LLC 5001657 042798

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death