BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PUMP

    MDR report key: 884032 · Received July 20, 2007

    Report

    Report Number
    2026095-2007-00035
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    June 22, 2007
    Report Date
    July 13, 2007
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS INCIDENT IS NOT AVAILABLE FOR EVALUATION. OUR RESULTS AND CONCLUSION ARE BASED ON THE INFORMATION THAT WAS GIVEN TO I-FLOW BY THE INITIAL REPORTER. THE LOT NUMBER OF THE PUMP WAS UNK, AND AS A RESULT, I-FLOW WAS UNABLE TO CONDUCT A HISTORICAL REVIEW TO DETERMINE SIMILAR PROBLEMS WITH A SPECIFIC LOT NUMBER. AT THIS TIME THIS COMPLAINT IS BEING CLOSED WITH NO FURTHER INVESTIGATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE WE WILL REOPEN THIS COMPLAINT. 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

    THE PT HAD A C-SECTION IN 2007 AND RECEIVED AN ON-Q PUMP. HER ON-Q PUMP WAS DISCONTINUED POST-OPERATION DAY 3. SHE WAS DIAGNOSED WITH A HEMATOMA PER MRI AND DEVELOPED AN INFECTION. SHE WAS THEN SENT TO THE ICU, WHERE SHE WAS TREATED WITH A COURSE OF IV ANTIBIOTICS. SHE WAS FOUND TO BE MRSA POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP NONE MEB I-FLOW CORP. PM015-A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other