BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC WITH ONDEMAND, 400ML X5+5ML/60MIN

    MDR report key: 2153009 · Received June 17, 2011

    Report

    Report Number
    2026095-2011-00165
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECS PRIOR TO RELEASE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 400ML AND FLOW RATE: 5ML/HR. PROCEDURE: OPEN REDUCTION INTERNAL FIXATION-RIGHT SHOULDER. CATHPLACE: RIGHT INTERSCALENE. HOTLINE RECEIVED CALL FROM NURSE THAT BOLUS BUTTON WAS STUCK IN THE DOWN POSITION WITH THE ORANGE REFILL INDICATOR IN THE TOP POSITION. ANESTHESIOLOGIST WAS NOTIFIED AND GAVE PERMISSION TO NURSE TO CHECK PATENCY OF THE CATHETER. NO KINKS OR ADD-ON FILTER NOTED. UPDATE: PER NURSE (B)(6) 2011, INFUSION STARTED ON (B)(6) 2011 AFTER SURGERY. PUMP REMOVED ON (B)(6) 2011 AND REPLACEMENT PUMP WAS NOT GIVEN TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC WITH ONDEMAND, 400ML X5+5ML/60MIN ELASTOMERIC PUMP MEB I-FLOW CORP. CB003 0B2791

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR