BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2191955 · Received July 22, 2011

    Report

    Report Number
    2026095-2011-00197
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    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 OR A LOT NUMBER, A COMPLETE 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: BUPIVACAINE 0.1%. FILL VOLUME: 500ML AND FLOW RATE: 0-4ML/HR. PROCEDURE: TOTAL KNEE ARTHROPLASTY. CATHPLACE: FEMORAL BLOCK. ANESTHESIOLOGIST NOTICED THAT THE BOLUS BUTTON WAS NOT FUNCTIONING AND THE ORANGE INDICATOR WAS IN THE DOWN POSITION. THE NEXT MORNING, THE ANESTHESIOLOGIST RETURNED TO FIND THE PUMP EMPTY. ANESTHESIOLOGIST REPORTS THAT THE PT WASN'T IN PAIN AND THE PT IS DOING FINE AND HAD NO PROBLEMS. 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 112157

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR