BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 23802651 · Received December 15, 2025

    Report

    Report Number
    9681834-2025-00227
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 15, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 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 WAS FILLED WITH GLUTARALDEHYDE-CONTAINING SALINE SOLUTION AND FIXED, THE HOUSING AND FILTER WERE REMOVED, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. - NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. THE FIBER LAYER WAS REMOVED GRADUALLY, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. - FORMATION OF BLOOD CLOTS WAS FOUND. - NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. THE OUTER CYLINDER WAS REMOVED FROM THE HEAT EXCHANGER, AND VISUAL AND MAGNIFYING INSPECTIONS OF THE HEAT EXCHANGER WERE PERFORMED. - FORMATION OF BLOOD CLOTS WAS FOUND ON THE HEAT EXCHANGER. ELECTRON MICROSCOPIC INSPECTION OF THE FIBER WAS PERFORMED. - ADHESION OF BLOOD CELL COMPONENTS SUCH AS RED BLOOD CELLS, DEFORMED RED BLOOD CELLS (ECHINOCYTE FORMATION), AND WHITE BLOOD CELLS, AND FORMATION OF A FIBRIN NET WERE OBSERVED. CONFIRMATION OF THE PUMP RECORD - AFTER THE START OF EXTRACORPOREAL CIRCULATION, BLOOD WAS CIRCULATING AT A CONSTANT FLOW RATE, BUT IT WAS FOUND THAT THE PRESSURE LOSS WAS GRADUALLY INCREASING. - IT WAS CONFIRMED THAT THE TEMPERATURE HAD DROPPED SINCE THE START OF EXTRACORPOREAL CIRCULATION, AND THAT THE PRESSURE LOSS HAD INCREASED ACCORDING TO THE TEMPERATURE CHANGE. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE - NO ANOMALY WAS FOUND. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE AND LOT NUMBER - NO OTHER SIMILAR REPORT WAS FOUND. RELEVANT IFU REFERENCE: THE IFU (CAPIOX FX25) INDICATES AS FOLLOWS REGARDING THE BLOOD CLOT FORMATION. - DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. - ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. 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: SETTING UP AS USUAL, THE EXTRACORPOREAL CIRCULATION BEGAN. AFTER THE START OF COOLING DOWN, THE PRESSURE INCREASED AS THE TEMPERATURE DECREASED. CIRCULATION WAS STOPPED AND THE OXYGENATOR WAS REPLACED AT A STABLE TIME. AFTER THE REPLACEMENT, THE PROCEDURE WAS CONTINUED WITHOUT ANY PROBLEMS. THE PATIENTS WERE LESS REACTIVE TO HEPARIN AND LESS PRONE TO PROLONGED ACTIVATED CLOTTING TIME (ACT), BUT EVENTUALLY MAINTAINED ACT FOR APPROXIMATELY 400 SECONDS. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720574 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-FX25REV 250604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention