BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 22325251 · Received June 25, 2025

    Report

    Report Number
    9681834-2025-00105
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 24, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AS THIS PRODUCT CODE IS BULK PRODUCT. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: PERFUSIONIST. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE - NO ANOMALY WAS FOUND. PAST COMPLAINT FILE. - NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9, SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL DEVICE UPON RECEIPT - NO ANOMALY SUCH AS BREAKAGE WAS FOUND (REFER TO PAGE 1 AND 2 IN THE ATTACHMENT). AFTER RINSING AND DRYING THE ACTUAL DEVICE (PAGE 3), THE AMOUNT OF OXYGEN TRANSFER AND CARBON DIOXIDE GAS REMOVAL WERE MEASURED ACCORDING TO THE PRODUCT INSPECTION PROCEDURE - IT WAS CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. [BOVINE BLOOD CONDITIONS] HB: 12G/DL, TEMP.: 37°C., PH: 7.4, SVO2: 65%, PVCO2: 45MMHG [CIRCULATION CONDITIONS] BLOOD FLOW RATE: 5L/MIN AND 3L/MIN, V/Q:1, FIO2: 100% [O2 TRANSFER VOLUME] @5L/MIN: 306ML/MIN., @3L/MIN: 202ML/MIN [CO2 REMOVAL VOLUME] @5L/MIN: 247ML/MIN., @3L/MIN: 173ML/MIN CONFIRMATION OF BLOOD GAS DATA WHEN USING THE OXYGENATOR - [10:35] AT THE START OF CARDIOPULMONARY BYPASS, BLOOD FLOW RATE: 4.5L/MIN, GAS FLOW RATE: 3L/MIN, AND FIO2: 80%. - [10:51] PO2: 15KPA (112.5MMHG), PCO2: 5.7KPA (42.8MMHG), AND CIRCULATION CONDITIONS AT THAT TIME WERE GAS FLOW RATE: 5L/MIN AND FIO2: 90%. - [11:30] GAS FLOW RATE WAS INCREASED TO 10L/MIN, FIO2 TO 100%, PCO2 HAD DECREASED TO 5KPA (37.5MMHG), BUT PO2 REMAINED UNCHANGED AT 15KPA (112.5MMHG). [11:35] PO2 HAD INCREASED TO 35KPA (262.5MMHG). [AFTER 13:00] FIO2 WAS 100%, BUT PO2 WAS GRADUALLY DECREASING. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE - NO ANOMALY WAS FOUND. PAST COMPLAINT FILE - NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT# WAS FOUND. MANUFACTURING DATE: MAY 24, 2024 EXPIRATION DATE: APRIL 30, 2027 UDI NO: N/A AS THIS PRODUCT CODE IS BULK PRODUCT. BASED ON THE INVESTIGATION RESULT, THE GAS EXCHANGE PERFORMANCE OF ACTUAL DEVICE AFTER RINSING MET THE FACTORY'S SPECIFICATIONS, AND NO ANOMALY WAS FOUND. FROM THE INFORMATION THAT THE FLOW RATE AT THE START OF CIRCULATION WAS 4.5L/MIN, AS A POSSIBLE CAUSE OF THIS CASE, IT WAS LIKELY THAT THE ACTUAL DEVICE WAS BEING USED ON A PATIENT WITH A LARGE BODY SURFACE AREA, AND THE PERFORMANCE WAS INSUFFICIENT WITH THE FX15 SIZE OXYGENATOR. HOWEVER, SINCE NO ANOMALY WAS FOUND IN THE ACTUAL DEVICE, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. THE IFU (CAPIOX FX15) HAS THE FOLLOWING WARNINGS, METHOD OF OPERATION AND PRECAUTION REGARDING GAS EXCHANGE FAILURE. - START GAS SUPPLY WITH V/Q=1, AND FIO2=100%, THEN MAKE ADJUSTMENTS BASED ON BLOOD GAS MEASUREMENTS. - MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. A. CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. - TO DECREASE PAO2, DECREASE FIO2. - TO INCREASE PAO2, INCREASE FIO2. B. CONTROL PACO2 BY CHANGING THE TOTAL GAS FLOW. - TO DECREASE PACO2, INCREASE TOTAL GAS FLOW. - TO INCREASE PACO2, DECREASE TOTAL GAS FLOW. - UPON PATIENT REWARMING, ADJUST O2 CONCENTRATION, GAS FLOW RATE AND BLOOD FLOW RATE BY INCREASING THEM AS NEEDED BASED ON AN INCREASE IN PATIENTS' 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. - A PHENOMENON CALLED WET LUNG MAY OCCUR WHEN WATER CONDENSATION OCCURS INSIDE FIBERS OF MICROPOROUS MEMBRANE OXYGENATORS WITH BLOOD FLOWING EXTERIOR TO THE FIBERS. THIS MAY OCCUR WHEN OXYGENATORS ARE USED FOR A LONGER PERIOD OF TIME. IF WATER CONDENSATION AND/OR A DECREASE IN PAO2 AND/OR AN INCREASE IN PACO2 IS NOTED DURING EXTENDED OXYGENATOR USE, BRIEFLY INCREASING THE GAS FLOW RATE MAY IMPROVE THE PERFORMANCE. INCREASE GAS FLOW RATE, TO 15 L/MIN FOR 10 SECONDS. DO NOT REPEAT THIS FLUSHING TECHNIQUE, EVEN IF OXYGENATOR PERFORMANCE IS NOT IMPROVED. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEY HAD A FAILING OXYGENATOR DURING A CARDIOPULMONARY BYPASS. THERE WAS NOT EFFICIENT GAS EXCHANGE EVEN WITH HIGH FLOWS. THEY WERE ABLE TO FINISH THE PROCEDURE WITHOUT CHANGING THE OXYGENATOR. THE TYPE OF PROCEDURE WAS A FREESTYLE AND RECONSTRUCTION OF AORTA MITRAL JUNCTION AS A RESULT OF ENDOCARDITIS. PROCEDURE DETAILS: 10:35 - START OF CPB (CARDIOPULMONARY BYPASS), COOLED TO 32°C, 4.5 LPM BLOOD FLOW, HEMATOCRIT 28-30, PCO2: 5.7 KPA. GAS FLOW: 3 LPM, FIO2: 80%. 10:50 - AORTIC CLAMP APPLIED. 10:51 - START OF PULSATILE FLOW. GAS FLOW: 5 LPM, FIO2: 90%, ARTERIAL POST-OXYGENATION PO2: 15 KPA, PCO2: 5.7 KPA. 11:30 - GAS FLOW: 10 LPM, FIO2: 100%, ARTERIAL POST-OXYGENATION PO2: 15 KPA, PCO2: 5 KPA. 11:35 - PULSATILE FLOW STOPPED FOR 2 MINUTES, GAS FLOW: 10 LPM, FIO2: 100%, ARTERIAL POST-OXYGENATION PO2 RISING TO 35 KPA, PCO2: 5 KPA. 13:00 - GAS FLOW: 10 LPM, FIO2: 100%, ARTERIAL POST-OXYGENATION PO2: 13 KPA, PCO2: 4.6 KPA. 13:20 - PULSATILE FLOW DEFINITIVELY STOPPED. 13:30 - GAS FLOW: 25 LPM (USING AN OXYGEN CYLINDER), FIO2: 100%, ARTERIAL POST-OXYGENATION PO2: 18 KPA, PCO2: 4.5 KPA. 14:15 - GAS FLOW: 12 LPM, FIO2: 100%, ARTERIAL POST-OXYGENATION PO2: 10 KPA, PCO2: 4.6 KPA. 14:40 - AORTIC CLAMP REMOVED, VENTILATION THROUGH THE LUNGS RESUMED: GAS FLOW: 12 LPM, FIO2: 100%, ARTERIAL POST-OXYGENATION PO2: 15 KPA, PCO2: 4.6 KPA. 15:15 - AORTIC CLAMP REAPPLIED, GAS FLOW: 12 LPM, FIO2: 100%, ARTERIAL POST-OXYGENATION PO2: 6 KPA, PCO2: 4.3 KPA. 15:25 - AORTIC CLAMP REMOVED, GAS FLOW: 12 LPM, FIO2: 100%, VENTILATION THROUGH LUNGS RESUMED, PCO2: 4.7 KPA. 15:27 - WEANING FROM CPB, 2.5 LPM BLOOD FLOW, GAS FLOW: 12 LPM, FIO2: 100%, ARTERIAL POST-OXYGENATION PO2 RISING TO 40 KPA, PCO2: 4 KPA. 15:40 - WEANED OFF CPB. NOTE: THE BLOOD GAS VALUES WERE MEASURED USING A CDI 550, WHICH WAS FREQUENTLY CALIBRATED WITH A BLOOD GAS ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064212 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA ZZ*FX15EA 240624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown