BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC SAF/PCA, 400 ML, 2-14 ML/HR+5 ML/30

    MDR report key: 2433375 · Received January 9, 2012

    Report

    Report Number
    2026095-2011-00463
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 15, 2011
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    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 F/U REPORT WILL BE FILED WHEN INVESTIGATION WAS BEEN COMPLETED. I-FLOW PROVIDES "WARNINGS" ON ITS ON-Q WITH ONDEMAND DFU WHICH STATES THE FOLLOWING: WARNINGS: 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 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 THE CLAMP CLOSED. PUMP SHOULD BE REPLACED IF APPROPRIATE, OR IF INDICATOR REMAINS IN THE UPPERMOST POSITION, SOMETHING MAY BE IMPENDING 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.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 500 ML. FLOW RATE: 14. PROCEDURE: UNK. CATHPLACE: UNK. PUMP WAS ATTACHED TO THE CATHETER AT 19:00PM ON (B)(6) 2011. THE MORNING OF THE (B)(6) 2011, THE BOLUS BUTTON WAS STUCK DOWN AND WOULD NOT POP BACK UP. THE PUMP WAS ATTACHED TO AN ARROW CATHETER. TROUBLESHOOTING WAS NOT CONDUCTED. PUMP WAS CHANGED. MODEL CB006 ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC SAF/PCA, 400 ML, 2-14 ML/HR+5 ML/30 ELASTOMERIC PUMP MEB I-FLOW, LLC 5001780 192432

    Patients

    Seq Age Sex Outcome Treatment
    1