BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q, 400ML, 2-14ML/HR SAF, PUMP

    MDR report key: 2143094 · Received June 23, 2011

    Report

    Report Number
    2026095-2011-00171
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 1, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE REC'D FOR EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. RESULTS: WITHOUT THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. IF ADD'L INFO PERTINENT TO THIS COMPLAINT, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: NAROPIN 0.2%. FILL VOLUME: 400ML & FLOW RATE: 6ML/HR. PROCEDURE: RIGHT SHOULDER TAS WITH SAD AND RCR. CATH PLACE: INTERSCALENE BRACHIAL PLEXUS. PUMP EMPTIED IN ABOUT 40 HOURS. PT HAD SURGERY ON (B)(6), 2011, AND PUMP WAS PLACED AFTER THAT. PT SAYS SHE HAD TROUBLE BREATHING ON (B)(6), 2011. SHE THINKS AS A RESULT OF THE MEDICATION, AND HER SISTER HELPED HER REMOVE THE PUMP ON (B)(6), 2011. PT HAS CONTACTED ANESTHESIOLOGY ABOUT THIS ISSUE. DATE OF EVENT: (B)(6), 2011. PER DFU: LABELED FILL VOLUME: 400ML. MAXIMUM FILL VOLUME: 550ML. SAF FLOW RATE: 2,4,6,8,10,12,14 ML/HR. DELIVERY ACCURACY: WHEN FILLED TO THE LABELED VOLUME, FLOW ACCURACY IS + OR - 20% OF THE LABELED RATES WHEN INFUSION IS STARTED 0-8 HOURS AFTER FILL AND DELIVERING NORMAL SALINE AS THE DILUEN AT 22 DEGREE CELSIUS / 72 DEGREE FAHRENHEIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q, 400ML, 2-14ML/HR SAF, PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. P400X2-14 132381

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other