BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C BLOC: 400ML, 2-14ML/HR SELECT-A-FLOW

    MDR report key: 2882999 · Received December 18, 2012

    Report

    Report Number
    2026095-2012-00376
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 19, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT HAS BEEN RECEIVED FOR EVALUATION AND INVESTIGATION. RESULTS: RESULTS ARE PENDING INVESTIGATION. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 550ML. FLOW RATE: 4ML - 6ML/HR. PROCEDURE: KNEE SURGERY. CATHPLACE: RIGHT FEMORAL NERVE. PATIENT CONTACT: YES. PHARMACY REPORTED THAT THEY HAD AN ON-Q PUMP COMPLETE IT'S DELIVERY OF SOLUTION WELL AHEAD OF IT'S SCHEDULED RUN TIME. THE PUMP WAS 400ML FILLED TO 550ML. SET TO DELIVER 4ML/HR INITIALLY ((B)(6) 2012 AT 13:30) THEN INCREASED TO 6ML/HR AT (B)(6) 2012 20:00. THE PUMP WAS FOUND EMPTY AT OR ABOUT 09:00 (B)(6) 2012. LT WAS WEIGHT CHECKED BEFORE FILLING AND AFTER, VERIFYING FILL QUANTITY OF 550ML. PATIENT IS FINE AND WAS DISCHARGED WITH A NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C BLOC: 400ML, 2-14ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB I-FLOW, LLC CB004 0200710260

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR