BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 24512330 · Received March 4, 2026

    Report

    Report Number
    9681834-2026-00038
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 5, 2026
    Report Date
    March 4, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A4: WEIGHT: 54.6 KGS. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED . D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. D10: CONCOMITANT MEDICAL PRODUCTS:REVOLUTION PHYSIO 050300700J, CDI 500 SHUNT SENSOR CV-510H1, MYOCARDIAL PROTECTION CIRCUIT (CUSTOM) JK-CP37304 040-04HIPEX, HEMOCON CIRCUIT KCG-MUF, RAP EVF FEMORAL VENOUS CANNULA 200-150 23/25 FR, DIRECT KIT 200-120, BIO-MEDICUS NEXTGEN ARTERIAL CANNULA 96570-117 17 FR, INSERTION NEEDLE 96552, JMS DOUBLE-LUMEN CP CANNULA P3 (CUSTOM FOR MICS) JK-WCP30, CARDIOPULMONARY BYPASS CANNULA FLEXMATE ADAPTER KIT ADKN-04, CARDIOPULMONARY BYPASS CANNULA FLEXMATE WARIUS VENT CATHETER VCKN-S-18K 18 FR, FLEXMATE HEPARIN-COATED CATHETER SUN-18, FLEXMATE PERICARDIAL SUMP CATHETER SUN-18, EXTRA BOWL SET X/225 04253J E3: OCCUPATION: CLINICAL ENGINEER G4: 510(K) NO.: K130520. APPEARANCE CONFIRMATION OF THE ACTUAL DEVICE UPON RECEIPT (VISUAL INSPECTION): NO ANOMALY SUCH AS DAMAGE WAS FOUND. THE ACTUAL DEVICE, AFTER HAVING BEEN RINSED AND DRIED, WAS TESTED FOR THE O2 TRANSFER VOLUME AND CO2 REMOVAL PERFORMANCE IN ACCORDANCE WITH THE PRODUCT INSPECTION PROTOCOL: IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. [BOVINE BLOOD CONDITIONS] HB: 12G/DL, TEMP.: 37°C., PH: 7.4, SVO2: 65%, PVCO2: 45 MMHG [CIRCULATION CONDITIONS] BLOOD FLOW RATE: 6L/MIN AND 4L/MIN, V/Q:1, FIO2: 100% [O2 TRANSFER VOLUME] @6L/MIN:387 ML/MIN., @4L/MIN: 278 ML/MIN [CO2 REMOVAL VOLUME] @6L/MIN: 322 ML/MIN., @4L/MIN: 239 ML/MIN. THE CONTENTS OF THE PUMP RECORD WERE CHECKED AND THE FOLLOWING WAS CONFIRMED: THE FIRST RECORDED PACO2 AFTER STARTING EXTRACORPOREAL CIRCULATION WAS 33.8MMHG. AFTERWARDS, PACO2 GRADUALLY INCREASED, REACHING A MAXIMUM OF 81 MMHG. THE INFORMATION WAS OBTAINED THAT THE GAS FLOW RATE WAS INCREASED TO 8 L/MIN, AND PACO2 HAD DECREASED TO APPROXIMATELY 40 MMHG. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE FOUND NO ANOMALY. NO OTHER SIMILAR ISSUE HAS BEEN REPORTED. BASED ON THE INVESTIGATION RESULT, THE GAS TRANSFER PERFORMANCE OF ACTUAL DEVICE AFTER RINSING MET THE FACTORY'S SPECIFICATIONS, AND NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. AS THE CAUSE OF THIS EVENT, IT WAS THOUGHT POSSIBLE THAT THE PACO2 WAS ALSO HIGH DUE TO THE HIGH PCO2 OF THE BLOOD FLOWING INTO THE OXYGENATOR, BUT IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE. THE INSTRUCTIONS FOR USE (IFU) (CAPIOX FX25) INDICATES AS FOLLOWS REGARDING THE GAS TRANSFER 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." 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

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING CIRCULATION, IT WAS OBSERVED CO2 WAS NOT REMOVED PROPERLY, AND THE DEVICE COULD BE RUN BY INCREASING OXYGEN FLOW RATE UP TO 8L/MIN. AIR SUPPLY OF CO2 WAS NOT DIFFERENT FROM USUAL. HOWEVER, IT WAS USED WITH DECREASING CO2 CONCENTRATION TO HANDLE POOR CO2 REMOVAL. THERE WAS NO PATIENT INJURY, HARM, MEDICAL OR SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568227 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-XRX53451A 250221

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female