BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1001451 · Received February 12, 2008

    Report

    Report Number
    2026095-2008-00012
    Event Type
    Other
    Date Received
    February 12, 2008
    Date of Event
    December 26, 2007
    Report Date
    January 11, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE INVOLVED IN THIS COMPLAINT HAS BEEN RECEIVED AND IS BEING EVALUATED AND INVESTIGATED. THE TESTING HAS NOT BEEN COMPLETED BY TIME OF FILING OF THIS MDR. THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED THAT THE PUMP FLOWED TOO FAST, COMPLETING INFUSION 4 DAYS EARLY. IF ADDITIONAL INFORMATION IS RECEIVED PERTINENT TO THIS INCIDENT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP EMPTIED 4 DAYS BEFORE THE END OF INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. LT 100-200 682067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other