BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP 400 ML, 4ML/HR (2+2 DUAL SITE)

    MDR report key: 2520448 · Received April 4, 2012

    Report

    Report Number
    2026095-2012-00049
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 12, 2012
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE WAS REPORTED TO BE AVAILABLE. RESULTS: IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT. I-FLOW PROVIDES A "CAUTION" ON ITS DFU FOR ON-Q WITH SELECT-A-FLOW 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 CENTIGRADE, 72 DEGREES FAHRENHEIT) AS THE OPERATING ENVIRONMENT. FLOW RATE WILL INCREASE APPROX 1.4% PER 1 DEGREE FAHRENHEIT/0.6 DEGREE CENTIGRADE INCREASE IN TEMPERATURE AND WILL DECREASE APPROX 1.4% PER 1 DEGREE FAHRENHEIT/0.6 DEGREE CENTIGRADE DECREASE IN TEMPERATURE.

    Description of Event or Problem · 1

    DRUG/DILUENT: BUPIVACAINE 0.5%. FILL VOLUME: 200 ML. FLOW RATE: 4.0ML/HR. PROCEDURE: THORACOTOMY. CATHPLACE: PERICARDIUM. PT EXPERIENCED SEIZURE WITH NA LEVEL AT 122.5. THE EXPECTED INFUSION PERIOD WAS 50 HOURS. THE INFUSION WAS FINISHED IN 31 HOURS AND 43 MINUTES. PT IS DOING WELL AND RECOVERING. RESPIRATORY RATE AT 6 APPROX 8 HOURS POSTOPERATIVELY; SEIZURE LIKE ACTIVITY APPROX 11 HOURS POSTOPERATIVE. INTERVENTION TREATMENT UNK, PT WAS IN CTU AND TRANSFERRED TO ICU. PT WAS DISCHARGED ON (B)(6) 2012, IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP 400 ML, 4ML/HR (2+2 DUAL SITE) ELASTOMERIC PUMP MEB I-FLOW CORPORATION 101367600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other