BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4688456 · Received April 10, 2015

    Report

    Report Number
    2026095-2015-00123
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 14, 2015
    Report Date
    March 17, 2015
    Manufacturer
    HALYARD
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: METHODS: ACTUAL DEVICE WAS RECEIVED FOR AN EVALUATION AND INVESTIGATION. A VISUAL INSPECTION, FLOW RATE ACCURACY TEST AND PRESSURE POT TEST WERE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE REPORTED MODEL AND LOT NUMBER. RESULTS: THE PUMP WAS RETURNED EMPTY WITH THE SELECT-A-FLOW (SAF) SET TO 10ML/HR. THE PUMP WAS REFILLED TO THE NOMINAL FILL VOLUME OF 400ML. THE PINCH CLAMP WAS OPENED AND THE PUMP INFUSED AT ALL SAF FLOW RATES. FLOW ACCURACY TESTING WAS PERFORMED WITH THE SAF SET TO 10ML/HR. AFTER 30 HOURS OF TESTING, THE PUMP YIELDED A FLOW RATE THAT WAS WITHIN SPECIFICATIONS WITH A PLUS/MINUS 20 PERCENT TOLERANCE. THE PRESSURE POT TESTING WAS PERFORMED ON THE SAF UNIT FLOW RATES 2ML/HR, 4ML/HR, 8ML/HNR AND 14ML/HR WITHOUT THE FILTER. THE SAF UNIT WAS DETACHED FROM THE PUMP. THE SAF UNIT WAS CONNECTED TO A PRESSURE GAUGE. THE SAF FLOW RATES 2ML/HR, 4ML/HR, 8ML/HR AND 14ML/HR YIELDED A FLOW RATE THAT WAS WITHIN SPECIFICATIONS WITH A PLUS/MINUS 20 PERCENT TOLERANCE. CONCLUSIONS: THE INVESTIGATION SUMMARY CONCLUDED THAT A FAST FLOW WAS NOT OBSERVED. DURING THE FLOW ACCURACY TEST, THE PUMP MET SPECIFICATIONS. DURING PRESSURE POT TESTING, ALL FLOW RATES MET SPECIFICATIONS USING THE AVERAGE BLADDER PRESSURE. THE DHR WAS REVIEWED FOR THE LOT NUMBER OF THE MANUFACTURED UNIT. THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. CONCLUSIONS: THE INVESTIGATION SUMMARY CONCLUDED THAT A FAST FLOW WAS NOT OBSERVED. DURING THE FLOW ACCURACY TEST, THE PUMP MET SPECIFICATIONS. DURING PRESSURE POT TESTING, ALL FLOW RATES MET SPECIFICATIONS USING THE AVERAGE BLADDER PRESSURE. BASED ON THE INVESTIGATION PERFORMED THE COMPLAINT IS NOT CONFIRMED. THE INSTRUCTIONS FOR USE (IFU) SPECIFIES THE FOLLOWING: THERE ARE SEVERAL FACTORS THAT MAY AFFECT THE FLOW RATE INCLUDING FILL VOLUME, TEMPERATURE, VISCOSITY OF THE DRUG SOLUTION, PUMP POSITION, STORAGE TIME AND EXTERNAL PRESSURE. "DELIVERY ACCURACY: WHEN FILLED TO THE LABELED VOLUME, SELECT-A-FLOW DEVICE ACCURACY IS PLUS/MINUS 20 PERCENT OF THE LABELED RATES WHEN INFUSION IS STARTED 0-8 HOURS AFTER FILL AND DELIVERING NORMAL SALINE AS A DILUENT AT 22 DEGREES C/72 DEGREES F. THE COMPLAINTS HANDLING DATABASE WAS REVIEWED FOR THE REPORTED PRODUCT LOT NUMBER AND NO COMPLAINTS HAVE BEEN ISSUED FOR THE SAME REPORTED LOT NUMBER. A TECHNICAL BULLETIN (MK-00538), FACTORS AFFECTING FLOW RATE, WAS SENT TO THE CUSTOMER. 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.

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RECEIVED FOR AN EVAL. THE EVAL OF THE PUMP IS ANTICIPATED, BUT NOT YET BEGUN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS CURRENTLY IN PROCESS FOR THE LOT NUMBER OF THE DEVICE. RESULTS: THERE ARE NO TESTING RESULTS AVAILABLE AS THE INVESTIGATION AND EVAL ARE CURRENTLY IN PROGRESS. CONCLUSIONS: ONCE THE ANALYSIS AND INVESTIGATION ARE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    PLEASE REF: 2026095-2015-00122/(B)(4). INCIDENT # 2 OF 2. FILL VOLUME: 550ML. FLOW RATE: 8ML/HR AND 10ML/HR. PROCEDURE: TARSOMETATARSAL FUSION. CATHPLACE: POPLITEAL NERVE BLOCK. INFUSION STARTED: (B)(6) 2015 AT 1200. INFUSION ENDED: (B)(6) 2015 AT 1500. IT WAS REPORTED THAT A PUMP INFUSION ENDED SOONER THAN EXPECTED. THE PUMP WAS REPLACED WITH ANOTHER PUMP AND THE SECOND PUMP ALSO EMPTIED WITHIN 24 HOURS. ADDITIONAL INFO WAS RECEIVED ON 03/26/2015. THE INCIDENT WAS DESCRIBED AS, "THE PUMP WAS DELIVERING MEDS TOO FAST". THE PUMP INFUSION RAN AT 8ML/HR FOR 10 HOURS AND THEN 10ML/HR FOR 16 HOURS. THE PUMP WAS EMPTY AFTER 26 HOURS. NO PT INJURY WAS REPORTED. ADDITIONAL INFO WAS REQUESTED, HOWEVER IS NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    FILL VOLUME: 400ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240244 ON-Q C-BLOC 400ML, 2-14ML; HR SELECT-A-FLOW ELASTOMERIC PUMP MEB HALYARD CB004 0300007437

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR