BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1028209 · Received April 11, 2008

    Report

    Report Number
    2026095-2008-00031
    Event Type
    Death
    Date Received
    April 11, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 13, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE INFORMATION PROVIDED INDICATED THAT THE PATIENTS DEVELOPED AN INFECTION AFTER THE USE OF THE ON-Q PUMP. IT WAS ALSO REPORTED THAT A PT DIED, BUT NO EXPLANATION OR FURTHER DETAILS WAS PROVIDED. ALL I-FLOW PRODUCTS ARE STERILIZED AND SEALED IN APPROPRIATE PACKAGING, TO BE OPENED ONLY IN A STERILE ENVIRONMENT BY INDIVIDUALS TRAINED IN STERILE PROCEDURE. PRIOR TO RELEASE, ALL PRODUCTION LOTS ARE SUBJECTED TO STRINGENT LABORATORY TESTING TO ASSURE STERILITY. WITH THE ASSUMPTION THAT THE DEVICE WAS PROPERLY HANDLED BY THE CLINICAL PERSONNEL ASSOCIATED WITH THE SURGERY, THE DEVICE WAS INTRODUCED TO THE SURGICAL SITE IN A STERILE CONDITION. ANY INFECTION COMPLICATION FOLLOWING THEREAFTER IS MOST LIKELY DUE TO OTHER POSTOPERATIVE FACTORS. 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

    DURING A HALLWAY DISCUSSION, THE DR INDICATED TO THE SALES REPRESENTATIVE THAT TWO PATIENTS HAD DEVELOPED INFECTIONS FOLLOWING THE USE ON PAIN PUMPS. A STATEMENT WAS ALSO MADE THAT ONE PT HAD DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM025 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R