BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC: 400ML, 2-14ML/HR SAF + 5ML/30MIN

    MDR report key: 3070339 · Received April 17, 2013

    Report

    Report Number
    2026095-2013-00066
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WAS DISCARDED BY THE END USER. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. AT THIS TIME I-FLOW IS CONDUCTING A HISTORICAL EVALUATION OF THE REPORTED MODEL. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARIS FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.1%. FILL VOLUME: 400 ML. FLOW RATE: 4.0 ML/HR. PROCEDURE: TOTAL RIGHT KNEE REPLACEMENT. CATHPLACE: LUMBER PLEXUS. THE PUMP WAS STARTED AT 12 NOON ON (B)(6) 2013. IN THE MORNING OF (B)(6) 2013, THE PUMP HAD VERY LITTLE MEDICATION LEFT. THE PUMP WAS DISCONTINUED AND A NEW PUMP WAS CONNECTED TO THE PATIENT TO CONTINUE PAIN CONTROL THERAPY. THE PATIENT HAD NO SIGNS OR SYMPTOMS OF DRUG RELATED SIDE EFFECTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS NEEDED AS A RESULT OF THIS REPORTED INCIDENT. PATIENT IS REPORTED TO BE STABLE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164858 ON-Q C-BLOC: 400ML, 2-14ML/HR SAF + 5ML/30MIN ELASTOMERIC PUMP MEB I-FLOW, LLC CB006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR