BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 1511741 · Received October 14, 2009

    Report

    Report Number
    2026095-2009-00252
    Event Type
    Death
    Date Received
    October 14, 2009
    Date of Event
    January 29, 2009
    Report Date
    September 15, 2009
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED FOR INVESTIGATION AND EVALUATION. WITHOUT THE ACTUAL PRODUCT OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. IT WAS REPORTED THAT TWO ON-Q PUMPS WERE PLACED ON THE PATIENT. NO SPECIFICS ON THE FLOW RATE FOR EITHER PUMP WERE PROVIDED. THE DIRECTIONS FOR USE FOR ON-Q PAIN PUMPS CONTAIN A WARNING THAT STATES: TWO MEDICATIONS OR FLUIDS MUST BE ADMINISTERED PER INSTRUCTIONS PROVIDED BY THE DRUG MANUFACTURER. PHYSICIAN IS RESPONSIBLE FOR PRESCRIBING DRUG BASED ON EACH PATIENT'S CLINICAL STATUS (SUCH AS AGE, BODY WEIGHT, DISEASE STATE OF PATIENT, CONCOMITANT MEDICATIONS, ECT.). IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT BREAST REDUCTION SURGERY IN 2008, AND TWO (2) PAIN PUMPS WERE INSERTED (FILL VOLUME 400ML). AT ABOUT 6 DAYS LATER, PATIENT WAS FOUND DECEASED IN HER BED FROM ACUTE COMBINED DRUG TOXICITY OF BUPIVACAINE AND PROPOXYPHENE, AND OTHER ISSUES IDENTIFIED IN THE AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INFUSION PUMP MEB I-FLOW CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death