BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC SAF/PCA, 400 X 1-7 + 5ML/60MIN

    MDR report key: 2243975 · Received August 24, 2011

    Report

    Report Number
    2026095-2011-00222
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 25, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RESULTS - DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION, AND TESTING IS CURRENTLY BEING PERFORMED. CONCLUSIONS - A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.1%. FILL VOLUME: 400 ML. FLOW RATE: 7ML/HR. PROCEDURE: FEMORAL NERVE BLOCK. CATHPLACE: FEMORAL NERVE. BOLUS BUTTON NOT FUNCTIONING PROPERLY. BOLUS BUTTON WAS PUSHED BUT ORANGE INDICATOR WOULD NOT REFILL (STAYED AT LOWERMOST POSITION) SO PUMP WAS REMOVED FROM PATIENT. THIS HAPPENED WITH TWO PUMPS. BOLUS BUTTON IS NOT STUCK DOWN ON PUMPS. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC SAF/PCA, 400 X 1-7 + 5ML/60MIN ELASTOMERIC PUMP MEB I-FLOW CORP. CB005 142545

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR