BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3869833 · Received April 30, 2014

    Report

    Report Number
    2026095-2014-00052
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    December 21, 2013
    Report Date
    April 8, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICES ARE REPORTED TO BE RETURNING FOR AN EVALUATION AND INVESTIGATION. AT THIS TIME THEY ARE PENDING RETURN. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) IS IN PROGRESS FOR THE REPORTED LOT NUMBER. RESULTS: RESULTS WILL BE PROVIDED ONCE THE INVESTIGATION AND EVALUATION HAVE BEEN COMPLETED. CONCLUSIONS: THE INVESTIGATION IS ONGOING, ONCE THE DEVICES ARE RECEIVED AN EVALUATION WILL BE PERFORMED. ONCE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. 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: 0.125% ROPIVACAINE. FILL VOLUME: 450 ML. FLOW RATE: 14 ML/HR. PROCEDURE: BILATERAL MPFL. CATHPLACE: BILATERAL FEMORAL NERVE BLOCK. DATE OF SURGERY: (B)(6) 2013. THIS REPORT IS FOR PUMP 1 OF 2 (PLEASE REFERENCE 2026095-2014-00054/(B)(6) PUMP 2). A PHYSICIAN POSTED AN INQUIRY VIA THE I-FLOW PATIENT WEBSITE REGARDING AN INCIDENT OF FAST FLOW THAT OCCURRED WITH TWO QN-Q PUMPS USED ON ONE PATIENT. AS REPORTED BY THE PHYSICIAN: "I HAD A PATIENT WITH BILATERAL FEMORAL CATHETERS WHO HAD ONQ PUMPS PLACED ON EACH CATHETER. HE WAS 90+KG, AND THE PUMPS WERE STARTED NIGHT OF SURGERY (APPROX. 5PM), AND WERE BOTH EMPTY THE NEXT MORNING AT 7AM. THEY WERE 400 ML PUMPS (OVERFILLED TO 450 ML). MY FELLOW THOUGHT IT WAS MALFUNCTION, BUT I FELT THERE WERE OTHER ISSUES. HAVE YOU HAD THESE PUMPS MALFUNCTION? IT WOULD HAVE HAD TO DELIVER AT APPROXIMATELY MORE THAN DOUBLE THE MAX RATE ON THE PUMP (14 ML/HR WAS SET FOR HIM). AND BOTH AT ONCE?" THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HE WAS IN PAIN UNTIL THEY GOT THE PUMPS RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258975 ON-Q C-BLOC: 400 ML, 2-14 ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB I-FLOW LLC CB004 0200948130

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR OXYCODONE (DOSE NOT PROVIDED)| TYLENOL (DOSE NOT PROVIDED)| VALIUM (DOSE NOT PROVIDED)| DILAUDID IV (DOSE NOT PROVIDED)