BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 25148881 · Received May 12, 2026

    Report

    Report Number
    9681834-2026-00094
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Report Date
    May 12, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    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: K1300280 H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. SINCE THE ACTUAL DEVICE WAS NOT AVAILABLE AND THE LOT WAS UNKNOWN, THE INVESTIGATION OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. SINCE THE LOT NUMBER OF THE ACTUAL DEVICE WAS UNKNOWN, IT WAS NOT POSSIBLE TO INVESTIGATE THE MANUFACTURING HISTORY OR SHIPPING INSPECTION RECORD. SINCE THE LOT INFORMATION WAS UNKNOWN, IT WAS NOT POSSIBLE TO CONFIRM THE MANUFACTURING DATE OR EXPIRATION DATE. AS A RESULT OF INVESTIGATING THE COMPLAINT FILE, NO SIMILAR REPORT WAS FOUND REGARDING THE INVOLVED PRODUCT CODE FOR THE PAST THREE YEARS FROM OTHER FACILITIES. RELEVANT INSTRUCTIONS FOR USE (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 RECEIVED THE FOLLOWING REPORTED INFORMATION: THE OXYGENATOR HAD AN INCREASE IN INLET PRESSURE. THE DEVICE WAS NOT REPLACED AND WEANED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525999 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-FX05W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown