BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC: 600ML, 1-7ML/HR SAF + 1-7 ML/HR

    MDR report key: 3172384 · Received June 5, 2013

    Report

    Report Number
    2026095-2013-00103
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    I-FLOW, LLC.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE IS PENDING RETURN TO THE MANUFACTURE. RESULTS: AT THIS TIME THE DEVICE HISTORY RECORD IS PENDING REVIEW. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A FOLLOW-UP REPORT WILL BE FILED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: BUPIVACAINE 0.125%. FILL VOLUME: 700 ML. FLOW RATE: 4.0 ML/HR INITIALLY AND THEN SET TO 6 ML/HR. PROCEDURE: LEFT SHOULDER ARTHROSCOPY WITH SUBACROMIAL DECOMPRESSION, MANIPULATION UNDER ANESTHESIA. CATHPLACE: INTERSCALENE NERVE BLOCK. PATIENT CALLED ANESTHESIOLOGIST TO REPORT THE PUMP WAS EMPTY THE MORNING OF (B)(6). PATIENT REPORTED PAIN, THE ANESTHESIOLOGIST GAVE THE PATIENT A BOLUS (A SINGLE SHOT OF MEDICATION) THROUGH THE CATHETER AND THEN REPLACED THE PUMP. NO ADVERSE EVENT REPORTED. START OF INFUSION WAS ON (B)(6) 2013 AT BEDTIME (NO TIME SPECIFIED). END OF INFUSION WAS ON (B)(6) 2013 AT 8:20 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249160 ON-Q C-BLOC: 600ML, 1-7ML/HR SAF + 1-7 ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC. CB6004 0200887606

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR