BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC SAF/PCA

    MDR report key: 2142119 · Received May 26, 2011

    Report

    Report Number
    2026095-2011-00149
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN REC'D, 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 SPECIFICATIONS PRIOR TO RELEASE. THE DIRECTIONS FOR USE (DFU) (PN 1306085, REV. B) STATES: WARNING: IF THE BUTTON DOES NOT POP BACK UP WITHIN 30 MINUTES, CHECK POSITION OF ORANGE REFILL INDICATOR. IF INDICATOR IS IN THE LOWERMOST POSITION, CLOSE CLAMP. IF BUTTON POPS BACK UP WITHIN 10 MINUTES, OPEN CLAMP AND CONTINUE WITH INFUSION. IF BUTTON REMAINS STUCK, IT MAY RESULT IN A SIGNIFICANT INCREASE IN FLOW RATE TO PT. KEEP CLAMP CLOSED. PUMP SHOULD BE REPLACED IF APPROPRIATE. IF INDICATOR REMAINS IN THE UPPERMOST POSITION, SOMETHING MAY BE IMPEDING THE FLOW. CHECK FOR TUBING KINKS, CLOSED CLAMP OR PATENCY OF CONNECTED DEVICES SUCH AS CATHETER OR UNVENTED FILTER (VERIFY PATENCY) ACCORDING TO YOUR STANDARD PROTOCOL." RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSION: THE SAMPLE WILL BE EVALUATED WHEN REC'D AND A F/U UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 400 AND FLOW RATE: 6ML/HR. PROCEDURE: OPEN REDUCTION INTERNAL FIXATION, LEFT ANKLE FRACTURE. CATHPLACE: POPLITEAL BLOCK. BOLUS BUTTON KEPT STICKING AND WOULD NOT POP BACK UP. WHEN REP WENT TO CHECK ON THE PUMP, THE BOLUS SEEMED TO BE WORKING FINE. PUMP WAS REPLACED FOR PT. NO ADVERSE EVENT REPORTED. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC SAF/PCA ELASTOMERIC PUMP MEB I-FLOW CORP. CB005 112157

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR