BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3101765 · Received May 3, 2013

    Report

    Report Number
    2026095-2013-00084
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION. CURRENTLY THE DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. RESULTS: A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE LOT NUMBER REPORTED AND THE PRODUCTION LOT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS. 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 0.1%. FILL VOLUME: 400 ML. FLOW RATE: 10.0 ML/HR. PROCEDURE: RIGHT ROTATOR CUFF REPAIR. CATHPLACE: RIGHT INTERSCALENE. PATIENT'S WIFE REPORTED PUMP INFUSED TOO QUICKLY. IT WAS A 400ML PUMP SET AT 10ML/HR AND RAN IN 13 HOURS. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2013: INFUSION STARTED (B)(6) 2013 AT 15:00, (3:00PM). PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194984 ON-Q C-BLOC: 400ML, 2-14 ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB I-FLOW, LLC CB004 0200792485

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR