BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4704705 · Received April 17, 2015

    Report

    Report Number
    2026095-2015-00128
    Event Type
    Injury
    Date Received
    April 17, 2015
    Report Date
    March 24, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEVICE WAS REPORTED AS NOT AVAILABLE FOR RETURN AND ANALYSIS. THE REPORTER WAS UNABLE TO PROVIDE A LOT NUMBER; THUS, THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED. HOWEVER, A USE REVIEW WAS CONDUCTED. RESULTS: AS THE DEVICE AND LOT NUMBER WERE UNAVAILABLE FOR ANALYSIS, NO METHODS WERE PERFORMED. FOR THIS REASON RESULTS CANNOT BE OBTAINED. A LITERATURE ARTICLE WAS REVIEWED (GURNANEY ET AL. AMBULATORY CONTINUOUS PERIPHERAL NERVE BLOCKS IN CHILDREN AND ADOLESCENTS: A LONGITUDINAL 8-YEAR SINGLE CENTER STUDY. ANESTHESIA & ANALGESIA. MAR 2014; VOL 118, NO 3: 621-627). PER THE USE REVIEW LIMITED INFORMATION WAS PROVIDED REGARDING THE USE CONDITIONS DURING THE INFUSIONS; THEREFORE, IT CANNOT BE DETERMINED IF THE DEVICE WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE OR IF USER/FACILITY CONDITIONS MAY HAVE CAUSED OR CONTRIBUTED TO THESE EVENTS. THE INSTRUCTIONS FOR USE (IFU) SPECIFIES, "WARNING" "MEDICATIONS OR FLUIDS MUST BE ADMINISTERED PER INSTRUCTIONS PROVIDED BY THE DRUG MANUFACTURER. PHYSICIAN IS RESPONSIBLE FOR PRESCRIBING DRUG BASED ON EACH PATIENT¿S CLINICAL STATUS (SUCH AS AGE, BODY WEIGHT, DISEASE STATE OF PATIENT, CONCOMITANT MEDICATIONS, ETC.)." THE IFU ALSO SPECIFIES, "TO AVOID COMPLICATIONS, USE THE LOWEST FLOW RATE, VOLUME AND DRUG CONCENTRATION REQUIRED TO PRODUCE THE DESIRED RESULT." "IT IS THE RESPONSIBILITY OF THE HEALTHCARE PROVIDER TO MODIFY PATIENT GUIDELINES PROVIDED WITH THE PUMP AS APPROPRIATE FOR YOUR PATIENTS¿ CLINICAL STATUS AND MEDICATION PRESCRIBED." CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO HALYARD FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED EVENT. THE IFU SPECIFIES, "WARNING" "MEDICATIONS OR FLUIDS MUST BE ADMINISTERED PER INSTRUCTIONS PROVIDED BY THE DRUG MANUFACTURER." PER THE USE REVIEW, BASED ON INFORMATION PROVIDED BY THE DRUG MANUFACTURER, THE MEDICATION MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT OF METALLIC TASTE IN THE MOUTH. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    PLEASE REFERENCE: 2026095-2015-00127/15-00325(A), 2026095-2015-00129/15-00325(C) AND 2026095-2015-00130/15-00325(D). FILL VOLUME: 400ML, FLOW RATE: 6ML/HR, PROCEDURE: INTERSCALENE CONTINUOUS NERVE BLOCK, CATHPLACE: ASKU. A LITERATURE REVIEW WAS CONDUCTED AND AN INCIDENT OF A PATIENT REACTION WHILE USING A PUMP WAS REPORTED. THE STUDY REVIEWED WAS A LONGITUDINAL 8-YEAR ((B)(6) 2005 - (B)(6) 2011) SINGLE CENTER STUDY THAT FOCUSED ON AMBULATORY CONTINUOUS PERIPHERAL NERVE BLOCKS (CPNBS) USED ON POST-ORTHOPEDIC SURGERY IN PEDIATRIC PATIENTS. THE PUMPS WERE CONNECTED IN THE PACU. INFUSION RATE WAS BASED ON LOCATION OF THE CATHETER AND PATIENT'S WEIGHT. ALL PATIENTS HAD AN INITIAL EVALUATION IN THE PACU BY A PHYSICIAN OR NURSE PRACTITIONER FROM THE PAIN SERVICE. THE PATIENT RECEIVED A BOLUS OF 30ML OF 0.1% ROPIVACAINE FOLLOWED BY AN INFUSION 0.1% ROPIVACAINE AT 6ML/HR FOR 12 HOURS WHEREUPON THE PATIENT COMPLAINED OF A METALLIC TASTE IN THE MOUTH AND THE CATHETER WAS CLAMPED AND REMOVED AND THE SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258618 ON-Q C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB HALYARD - IRVINE CB004 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other PLEXOLONG NEEDLE UP NEEDLE 19.5 G,18 G 50 OR 100MM| POLYHAMIDE NONSTIMULATING CATHETER PAJUNK MEDICAL| STIMULONG CATHETER 20G 50CM PAJUNK MEDICAL SYSTEMS| MORPHINE (0.025-0.05MG/KG) BOLUS FOR PAIN > 3| ROPIVACAINE 0.1%