BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF

    MDR report key: 4912448 · Received July 14, 2015

    Report

    Report Number
    9681834-2015-00143
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 14, 2015
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 2 FOR MFG. REPORT # 9681834-2015-00143 TO PROVIDE THE PRODUCT CODE AND ADDITIONAL INFORMATION REGARDING THE PERFUSION RECORD RECEIVED FROM THE USER FACILITY. THE INVOLVED PERFUSION RECORD WAS REVIEWED. THE PATIENT'S BSA WAS 2.06M2. @ 9:02, CPB WAS INITIATED. @ 9:11, THE CROSS CLAMP WAS ADDED. @ 9:56, PACO2 WAS DECREASED TO 53MMHG AND PAO2 WAS INCREASED TO 224MMHG. @ 9:30, THE GAS FLOW RATE WAS INCREASED FROM 4.5L/MIN TO 8.0L/MIN. @ 10:39, PACO2 WAS DECREASED TO 43MMHG AND PAO2 WAS DECREASED TO 215MMHG. DURING RE-WARMING, THE PATIENT'S METABOLISM IS ACTIVATED. THIS INCREASES O2 CONSUMPTION AND DECREASES SVO2 AND A DECREASE IN SVO2 LEADS PAO2 TO GET DECREASED. THE BLOOD FLOW RATE WAS AROUND 4.0 - 4.6L/MIN WITH NO DECREASE IN THE VALUE. THIS INDICATES THAT THERE WAS NO THROMBUS FORMATION. BASED ON THE PERFUSION RECORD REVIEW RESULT, THE BELOW POSSIBILITIES CAN BE INFERRED AS A CAUSE OF THIS COMPLAINT. (1) (PACO2) LOWERED BLOOD TEMPERATURE LED CO2 GAS TO BE DIFFICULT TO BE REMOVED. (2) (PAO2) THE BLOOD FLOW RATE WAS NOT SUFFICIENT AGAINST THE PATIENT'S BSA. THIS LED SVO2 TO GET DECREASED AND THEN PAO2 TO GET DECREASED. THE DEVICE LABELING (IFU) DOES ADDRESS INSTRUCTIONS WITH STATEMENTS SUCH AS THE FOLLOWING: UPON PATIENT REWARMING ADJUST O2 CONCENTRATION, GAS FLOW RATE AND BLOOD FLOW RATE BY INCREASING THEM AS NEEDED BASED ON AN INCREASE IN PATIENT'S METABOLISM, FAILURE TO ADJUST THE GAS SUPPLY AND THE BLOOD FLOW RATE APPROPRIATELY MAY CAUSE INSUFFICIENT O2 SUPPLY NEEDED OR THE AMOUNT OF THE PATIENT'S GASEOUS METABOLISM. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    AS STATED, THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #1 FOR MFG. REPORT # 9681834-2015-00143 TO PROVIDE THE RETURN SAMPLE EVALUATION RESULTS, PROVIDE THE EXPIRATION DATE, PROVIDE THE DEVICE MANUFACTURING. THE ACTUAL SAMPLE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT DID NOT FIND ANY ANOMALIES WHICH WOULD RELATE TO A GAS LEAK OR INSUFFICIENT GAS TRANSFER PERFORMANCE. THE ACTUAL SAMPLE WAS RINSED, DRIED AND WAS TESTED FOR ITS GAS TRANSFER PERFORMANCE IN ACCORDANCE TO THE FACTORY'S SHIPPING INSPECTION PROTOCOL. BOVINE BLOOD WAS CIRCULATED IN THE OXYGENATOR MODULE. NO ANOMALIES WERE REVEALED IN THE GAS TRANSFER PERFORMANCE OF THE ACTUAL SAMPLE, WITH THE OBTAINED VALUES MEETING MANUFACTURER SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THE INVOLVED PRODUCT/LOT# COMBINATION HAS NOT BEEN REPORTED PREVIOUSLY. THE PERFUSION RECORD WAS NOT AVAILABLE FOR REVIEW. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE INVESTIGATION RESULTS VERIFIED THAT THE ACTUAL SAMPLE, AFTER HAVING BEEN RINSED AND DRIED, WAS THE NORMAL PRODUCT WITH NO ISSUE IN THE GAS TRANSFER PERFORMANCE. WITH DETAILED INFORMATION NOT AVAILABLE, THE CAUSE OF INSUFFICIENT GAS TRANSFER PERFORMANCE THE CUSTOMER EXPERIENCED CANNOT BE DETERMINED DEFINITELY. THE DEVICE LABELING (IFU) DOES ADDRESS INSTRUCTIONS WITH STATEMENTS SUCH AS THE FOLLOWING: (1) MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. (2) TO DECREASE PAO2, DECREASE FIO2. (3) TO INCREASE PAO2, INCREASE FIO2. CONTROL PAO2 BY CHANGING THE TOTAL GAS FLOW. (4) TO DECREASE PAO2, INCREASE TOTAL GAS FLOW. (5) TO INCREASE PAO2, DECREASE TOTAL GAS FLOW. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURING FACILITY FOR EVALUATION AND THE PRODUCT CODE WAS NOT PROVIDED BY THE USER FACILITY. A FOLLOW UP WILL BE SENT WITHIN 30 DAYS OF THIS REPORT BEING SENT. THE PRODUCTION PRODUCT CODE WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD OR PRODUCT RELEASE DECISION CONTROL SHEET AND COMPLAINT FILES. A REVIEW OF THE COMPLAINT FILE FOR ANY CAPIOX RELATED COMPLAINTS CONFIRMED NO OTHER REPORT WITH THE INVOLVED LOT NUMBER. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 2 FOR MFG. REPORT # 9681834-2015-00143 TO PROVIDE THE PRODUCT CODE AND ADDITIONAL INFORMATION REGARDING THE PERFUSION RECORD RECEIVED FROM THE USER FACILITY.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #1 FOR MFG. REPORT # 9681834-2015-00143 TO PROVIDE THE RETURN SAMPLE EVALUATION RESULTS, PROVIDE THE EXPIRATION DATE, PROVIDE THE DEVICE MANUFACTURING DATE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED INSUFFICIENT GAS EXCHANGE IN THE CAPIOX DEVICE DURING CARDIOPULMONARY BYPASS. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: (1) AFTER GOING ON BYPASS AT 1:1 AND 100% COOLED TO 34 AND HCT OF 30; (2) IT WAS NOTICED PO2 DROPPED TO 150'S AND CO2 STARTED TO CLIMB; (3) WENT TO 8 LPM (2:1) ON SWEEP TO KEEP CO2 AT 55-60; (4) COOLED TO 30 DEGREES; (5) CHECKED PUMP FOR GAS LEAKS; (6) ALSO TRIED GAS SOURCE FROM AN E TANK; (7) IT WAS REPORTED NO CHANGE; (8) DROPPED PATIENTS HCT TO 23 STORING BLOOD IN CELL SAVER AND DILUTING WITH NORMOSOL AND ALBUMIN; (9) THIS BROUGHT THE PO2 UP FROM THE 150'S TO THE 250-300 RANGE; (10) UPON REWARMING, PO2 DROPPED RATHER QUICKLY; (11) AS SOON AS CROSS CLAMP WAS UP THE SURGEON WAS NOTIFIED; (12) IT WAS REPORTED THEY VENTILATED AND WENT ON PARTIAL QB TO FINISH REWARMING AND REPERFUSING HEART; (13) BLOOD WAS GIVEN BACK PRIOR TO WEANING BYPASS; (14) PRODUCT WAS NOT CHANGED OUT; AND (15) SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456229 CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 150115

    Patients

    Seq Age Sex Outcome Treatment
    1