BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC WITH SAF, 400 ML, 2-14 ML.HR

    MDR report key: 2427273 · Received January 5, 2012

    Report

    Report Number
    2026095-2011-00458
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 9, 2011
    Report Date
    December 9, 2011
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. PRODUCT PENDING RECEIPT. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED. I-FLOW PROVIDES A "CAUTION" ON ITS DFU WHICH STATES THE FOLLOWING: CAUTIONS: DO NOT UNDER FILL PUMP. UNDER FILLING THE PUMP MAY SIGNIFICANTLY INCREASE THE FLOW RATE. FLOW RATE IS UNPREDICTABLE IF IT IS DIALED BETWEEN RATE SETTINGS. THE SELECT-A-FLOW DEVICE SHOULD BE WORN OUTSIDE THE CLOTHING AND KEPT AT ROOM TEMPERATURE. TEMPERATURE WILL AFFECT SOLUTION VISCOSITY, RESULTING IN FASTER OR SLOWER FLOW RATE. SELECT-A-FLOW HAVE BEEN CALIBRATED USING NORMAL SALINE (NS) AS THE DILUENT AND ROOM TEMPERATURE (22 DEGREES C, 72 DEGREES F) AS THE OPERATING ENVIRONMENT. FLOW RATE WILL INCREASE APPROXIMATELY 1.4% PER 1 DEGREE F/0.6 DEGREE C INCREASE IN TEMPERATURE AND WILL DECREASE APPROXIMATELY 1.4% PER 1 DEGREE F/0.6% DEGREE C DECREASE IN TEMPERATURE.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE, 020%. FILL VOLUME: 500 ML. FLOW RATE: 14 ML. PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. (REFERENCE 2026095-2011-00459 ((B)(4)) PUMP STARTED ON PT (B)(6) 2011 AT 0910. AT 0145, ON (B)(6) 2011, THE PUMP WAS CLAMPED OFF. BY VISUAL EXAMINATION PUMP WAS 2/3 TO 3/4 EMPTY. CATHETER WITHDRAWN ON (B)(6) 2011. NO ADVERSE EVENT OCCURRED. PT STATUS: UNREMARKABLE. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC WITH SAF, 400 ML, 2-14 ML.HR ELASTOMERIC PUMP MEB I-FLOW, LLC 101347200 182285

    Patients

    Seq Age Sex Outcome Treatment
    1