BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3980478 · Received June 5, 2014

    Report

    Report Number
    2026095-2014-00075
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 8, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED NOT TO BE RETURNING FOR AN ANALYSIS. THE LOT NUMBER WAS NOT AVAILABLE, THEREFORE, THE DEVICE HISTORY RECORDS (DHR) COULD NOT BE REVIEWED. HISTORY REVIEW WILL BE PERFORMED. RESULTS: AS NO DEVICE WAS AVAILABLE FOR AN EVALUATION NO METHODS WERE PERFORMED, THEREFORE, RESULTS CANNOT BE OBTAINED AT THIS MOMENT. CONCLUSIONS: AT THIS TIME THIS INCIDENT IS BEING FURTHER INVESTIGATED WITH THE REPORTED INFORMATION RECEIVED. SHOULD ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT BE RECEIVED, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. THE TECHNICAL BULLETIN "FACTORS AFFECTING FLOW RATE, ON-Q PAIN RELIEF SYSTEM" PROVIDE GUIDELINES AND FACTORS REGARDING FLOW RATES AS SPECIFIED BELOW: FLOW RATE ACCURACY SPECIFICATION IS BASED ON FILLING THE PUMP TO THE LABELED FILL VOLUME. FILLING THE PUMP LESS THAN THE LABELED VOLUME INCREASED FLOW RATE. THE FLOW CONTROLLER SHOULD BE AT ROOM TEMPERATURE (72 DEGREES F, 22 DEGREES C). TEMPERATURE WILL AFFECT FLUID VISCOSITY: FLOW RATE WILL INCREASE APPROXIMATELY 1.4% PER 1 DEGREE F/0.6 DEGREES C INCREASE IN TEMPERATURE. THE PUMP SHOULD BE POSITIONED AT APPROXIMATELY THE SAME LEVEL AS THE CATHETER SITE. POSITIONING THE PUMP ABOVE THIS LEVEL MAY INCREASE THE FLOW RATE. FLOW RATE ACCURACY SPECIFICATION IS BASED ON STARTING THE INFUSION WITHIN 0-8 HOURS AFTER FILLING. SQUEEZING OR LAYING ON THE PUMP MAY INCREASE FLOW RATE. A COPY OF THE TECHNICAL BULLETIN WILL BE PROVIDED TO THE CUSTOMER. THE DEVICE WAS NOT RETURNED TO I-FLOW FOR EVALUATION, THEREFORE, WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. 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

    FILL VOLUME: 400 ML. FLOW RATE: 6 ML/HR. PROCEDURE: INTERSCALENE BLOCKS FOR TOTAL SHOULDER REPLACEMENT. DATE OF SURGERY: (B)(6) 2014. (PLEASE REFERENCE 2026095-2014-00076/(B)(4)). IT WAS REPORTED BY AN ANESTHESIOLOGIST THAT THERE WERE 2 PUMPS FOR 2 INDIVIDUAL PATIENTS THAT SEEMED TO HAVE INFUSED FASTER THAN EXPECTED. PATIENT NUMBER 1: PATIENT WAS A (B)(6) YEAR OLD FEMALE. THE INFUSION PUMP STARTED AROUND 15:30 AT (6 ML/HR) ON (B)(6) 2014, AFTER A TOTAL SHOULDER REPLACEMENT SURGERY. THE PATIENT REGAINED SENSATION IN HER ARMS, STARTED FEELING PAIN AND REALIZED THE PUMP WAS EMPTY BETWEEN THE HOURS OF 7-9PM ON (B)(6) 2014. THE ANESTHESIOLOGIST STATED THAT HE EXPECTED THE PUMPS TO LAST AT LEAST 48 HOURS, BUT BOTH FINISHED WITHIN APPROXIMATELY 26-28 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329894 ON-Q C-BLOC: 400ML, 2-14 ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB I-FLOW, LLC CB004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 0.125% BUPIVACAINE