BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 23230593 · Received October 6, 2025

    Report

    Report Number
    9681834-2025-00181
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 6, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: UNKNOWN. G4: 510(K) NO.: K130520. 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. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND DETAILED INFORMATION WAS NOT AVAILABLE, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. 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 A BENTALL PROCEDURE, FOAM FORMATION IN THE VENOUS RESERVOIR AFTER 5 HOURS OF CBP TIME AND LEADS TO CHANGE THE OXY WITH ANOTHER FX25 OXYGENATOR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746201 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX25RW 240917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention