BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3070541 · Received April 17, 2013

    Report

    Report Number
    2026095-2013-00065
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RECEIVED FOR EVAL AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. RESULTS: TESTING IS CURRENTLY BEING PERFORMED ON THE RETURNED UNIT. THE DEVICE PASSED ALL MFG SPECS PRIOR TO RELEASE. CONCLUSIONS: A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, 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 LEFT KNEE REPLACEMENT. CATHPLACE: FEMORAL BLOCK. THE PUMP WAS STARTED AT 10 AM 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 PT TO CONTINUE PAIN CONTROL THERAPY. THE PT HAD NO SIGNS OR SYMPTOMS OF DRUG RELATED SIDE EFFECTS. NO PT INJURY OR MEDICAL INTERVENTION WAS NEEDED AS A RESULT OF THIS REPORTED INCIDENT. PT IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166297 ON-Q C-BLOC: 400ML, 2-14ML/HR SAF + 5ML/30MIN ELASTOMERIC PUMP MEB I-FLOW, LLC CB006 0200693655

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR