BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX®FX

    MDR report key: 23977566 · Received January 6, 2026

    Report

    Report Number
    9681834-2025-00247
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    December 8, 2025
    Report Date
    January 6, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE ADDITIONAL INFORMATION IN SECTION B5.

    Additional Manufacturer Narrative · 0

    D4: POTENTIAL LOT NUMBES: 240611, 240708, D4: EXPIRATION DATES: 31MAY2027, 30JUN2027, D4: UDI: N/A AT 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: VIGILANCE SPECIALIST. H4: DEVICE MANUFACTURE DATES: 11JUN2024, 08JUL2024. THE ACTUAL DEVICE WAS NOT RETURNED. 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 RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. SINCE THE ACTUAL DEVICE COULD NOT BE CONFIRMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OCCURRENCE. IN ORDER TO CLARIFY THE CAUSE, WE WOULD APPRECIATE YOUR COOPERATION IN OBTAINING THE ACTUAL DEVICE. THE INSTRUCTIONS FOR USE (IFU) (CAPIOX FX25) INDICATES AS FOLLOWS REGARDING 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." "A PHENOMENON CALLED WET LUNG MAY OCCUR WHEN WATER CONDENSATION OCCURS INSIDE FIBERS OF MICROPOROUS MEMBRANE OXYGENATORS WITH BLOOD FLOWING EXTERIOR TO THE FIBERS. THIS MAY OCCUR WHEN OXYGENATORS ARE USED FOR A LONGER PERIOD OF TIME. IF WATER CONDENSATION AND/OR A DECREASE IN PAO2 AND/OR AN INCREASE IN PACO2 IS NOTED DURING EXTENDED OXYGENATOR USE, BRIEFLY INCREASING THE GAS FLOW RATE MAY IMPROVE THE PERFORMANCE. INCREASE GAS FLOW RATE, TO 20 L/MIN FOR 10 SECONDS. DO NOT REPEAT THIS FLUSHING TECHNIQUE, EVEN IF OXYGENATOR PERFORMANCE IS NOT IMPROVED." TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION TO SECTIONS B5 AND H6 (HEALTH EFFECT - CLINICAL CODE AND HEALTH EFFECT - IMPACT CODE).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 13JAN2026: THE ONLY CONSEQUENCE WAS THAT BLOOD LOSS WAS RELATED TO THE INCIDENT, 1000 ML OF BLOOD TREATED BY THE CELL SAVER AND RE-TRANSFUSED TO THE PATIENT (300 ML LOST).

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THERE WAS LACK OF OXYGENATION DURING CARDIOPULMONARY BYPASS. THE EVENT DID NOT RESULT IN DELAYS OF THE SURGICAL PROCEDURE. DURING THE PROCEDURE, THERE WAS AN ABNORMALLY LOW PAO2 AT THE OXYGENATOR OUTPUT: 100 MM HG FOR AN FIO2 HIGHER THAN 90% SHORTLY AFTER THE START OF CPB. A CHANGE OF CIRCUIT DURING THE PROCEDURE RESOLVED THE PROBLEM. NO CLINICAL CONSEQUENCES WERE MENTIONED. IT WAS UNKNOWN IF THE PRODUCT WAS CHANGED OUT, IF THE SURGERY WAS COMPLETED SUCCESSFULLY, OR IF BLOOD LOSS OCCURRED. IT WAS UNKNOWN IF THE MALFUNCTION CAUSED AND CONTRIBUTED TO AN INJURY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 06JAN2026: THERE WAS NO DELAY IN THE MEDICAL PROCEDURE. THERE WAS A CHANGE OF CIRCUIT, VOLUME OF THE OLD CIRCUIT TREATED WITH CELL SERVER. THE PROCEDURE WAS CREATED SUCCESSFULLY. THE EVENT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204099 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA ZZ*FX25RW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown