BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOK: 400 ML, 2-14 ML/HR SELECT-A-FLOW

    MDR report key: 2871984 · Received December 11, 2012

    Report

    Report Number
    2026095-2012-00312
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 11, 2012
    Manufacturer
    I-FLOW, LLC
    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: THE DEVICE USED WAS RECEIVED FROM THE END USER FOR INSPECTION AND EVALUATION. RESULTS: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFORMATION FROM THIS INCIDENT HAS BEEN 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: ROPIVACAINE 0.2. FILL VOLUME: 500 ML/HR. FLOW RATE: 6.0 ML. PROCEDURE: FOOT ARCH. CATHPLACE: LEFT SCIATICA NERVE. CUSTOMER REPORTED A CB004 PUMP INFUSED TOO QUICKLY. NURSE LATER FOLLOWED UP WITH PATIENT'S MOTHER WHO STATED SHE MAY HAVE PULLED THE PUMP OFF TOO EARLY AS IT STILL HAD SOME MEDICATION IN IT. CUSTOMER STATED THAT THE PATIENT HAD SURGERY ON (B)(6) 2012, FOR LEFT CLUB FOOT REPAIR WITH CATHETER PLACED AT LEFT SCIATICA NERVE. PUMP WAS LOT 0200635384, 400ML PUMP FILLED TO 500 WITH 0.2% ROPIVACAINE. PUMP WAS STARTED (B)(6) AT 2:00PM AT 6ML/HR. PATIENTS MOTHER CALLED IN TO REPORT THAT THE PUMP SEEMED EMPTY ON (B)(6) AT 4:00PM AT WHICH TIME THE PUMP WAS PULLED. THE PATIENT'S MOTHER ALSO REPORTED THE DRUG HAD BEEN LEAKING FROM INCISION SITE. NO MEDICAL INTERVENTION OR INJURY/ ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOK: 400 ML, 2-14 ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB I-FLOW, LLC CB004 0200635384

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR