BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX®FX

    MDR report key: 24624496 · Received March 17, 2026

    Report

    Report Number
    9681834-2026-00048
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 17, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    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

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. 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. E3: OCCUPATION: CLINICAL ENGINEER. G4: 510(K) NO: K1300280. VISUAL INSPECTION OF THE ACTUAL DEVICE UPON RECEIPT - NO ANOMALY SUCH AS DAMAGE WAS FOUND. THE ACTUAL DEVICE WAS FILLED WITH SALINE SOLUTION CONTAINING A GLUTARALDEHYDE SOLUTION AND WAS FIXED, THE HOUSING AND FILTER WERE REMOVED, AND VISUAL AND MAGNIFYING INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. - NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. - NO ANOMALY WAS FOUND IN THE MESH DIAMETER OF THE FILTER. THE FIBER LAYER WAS REMOVED GRADUALLY, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. - BLOOD CELL COMPONENT ADHERED. - NO ANOMALY WAS FOUND IN FIBER WINDING CONDITION. THE OUTER CYLINDER WAS REMOVED FROM THE HEAT EXCHANGER, AND VISUAL AND MAGNIFYING INSPECTIONS OF THE HEAT EXCHANGER WERE PERFORMED. - BLOOD CLOT WAS NOT FORMED IN THE HEAT EXCHANGER. - NO ANOMALY SUCH AS OBSTRUCTION OF THE FLOW PATH WAS FOUND. ELECTRON MICROSCOPIC INSPECTION OF THE FIBER WAS PERFORMED. - IT WAS OBSERVED BLOOD CELL COMPONENTS SUCH AS RED BLOOD CELLS, DEFORMED RED BLOOD CELLS (ECHINOCYTE FORMATION), AND WHITE BLOOD CELLS ADHERED AND A FIBRIN NET WAS FORMED. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE - NO ANOMALY WAS FOUND IN THEM. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE/LOT NUMBER - NO OTHER SIMILAR REPORT WAS FOUND BASED ON THE INVESTIGATION RESULTS, IT WAS OBSERVED BLOOD CELL COMPONENTS ADHERED TO THE FIBERS OF THE ACTUAL DEVICE. HOWEVER, THERE WERE NO OBSTRUCTIONS IN THE FLOW PATH THAT WOULD HAVE INCREASED THE PRESSURE UP TO 1000MMHG, AND IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OCCURRENCE FROM THE INVESTIGATION OF THE ACTUAL DEVICE. RELEVANT IFU REFERENCE: - 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 CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT SINCE PRESSURE SUDDENLY INCREASED FROM 280MMHG TO 1000MMHG APPROXIMATELY FIFTEEN MINUTES AFTER THE PUMP STARTED, THE PUMP STOPPED AND THE OXYGENATOR WAS REPLACED. THEN, IT WAS SUCCESSFULLY CIRCULATED AND THE SURGERY WAS FINISHED. THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675194 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-FX05E 240718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O