BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX FX ADVANCE HOLLOW FIBER OXYGENATOR W INTEGRATED AF W HARDSHELL RES.

    MDR report key: 23212093 · Received October 3, 2025

    Report

    Report Number
    1124841-2025-00075
    Event Type
    Death
    Date Received
    October 3, 2025
    Date of Event
    August 29, 2025
    Report Date
    December 19, 2025
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K151791
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON OCTOBER 3, 2025. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: B1 (UPDATED REPORT TYPE) B2 (UPDATED OUTCOME ATTRIBUTED TO ADVERSE EVENT) B5 (ADDED DESCRIBE EVENT OR PROBLEM) G3 (DATE RECEIVED BY MANUFACTURER) G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT) H1 (UPDATED TYPE OF REPORTABLE EVENT) H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION) H6 (IDENTIFICATION OF EVALUATION CODES 3331, 4114, 3221, 4315). THE AFFECTED COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING AND INCOMING INSPECTION RECORDS OF THE ACTUAL DEVICE WERE REVIEWED AND WAS FOUND TO HAVE NO ANOMALIES. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCES EVALUATION CONCLUSION CODE 11.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. THE PATIENT SUCCUMBED TO A NEUROLOGICAL INJURY THAT WAS IDENTIFIED WHILE THE PATIENT WAS ON ECMO POST CARDIOTOMY. THE NEUROLOGIC INJURY WAS DESCRIBED AS WATERSHED ISCHEMIC CHANGED AND EMBOLIC LOAD.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR STARTED FAILING. AFTER ROUGHLY 4HRS OF USE THERE WAS A PRECIPITOUS DROP IN THE ABILITY TO OXYGENATE THE BLOOD. THROUGH TROUBLESHOOTING IT WAS QUICKLY IDENTIFIED THAT THE OXYGENATOR WAS FAILING. FLOWS WERE STILL ABLE TO BE ACHIEVED EASILY THROUGH THE OXYGENATOR OUR DELTA P WAS NOMINAL; TEMPERATURE MANAGEMENT WAS NOT IMPAIRED; THERE WAS A NOTICEABLE DECREASE IN CARBON DIOXIDE (CO2) CLEARANCE BUT A MARKED FAILURE TO OXYGENATE. THE PARTIAL PRESSURE OF OXYGEN (PAO2) WENT FROM 288 > 246 > 163 > 103 > 86 FROM 14:30 TO 15:37. IT WAS DECIDED TO REPLACE THE OXYGENATOR. THE EMERGENCY CHANGE-OUT PROTOCOL WAS INITIATED. COOLED TO 24C AND UNDERWENT A SHORT CIRCULATORY ARREST OF 165SEC. WE WERE ABLE TO MAINTAIN OXYGENATION ONCE WE COOLED. NO SIGNS OF ISCHEMIA WERE NOTED, CEREBRAL SATURATION VIA NEAR-INFRARED SPECTROSCOPY (NIRS) WAS WITHIN ACCEPTABLE RANGE OF BASELINE. ADDITIONALLY, THERE WAS NOTED TO BE SOME SLIGHT IRREGULARITIES INTERMITTENTLY WITH THE MEASURED PRE-OXY PRESSURE, WHICH WAS NOTICED AROUND THE 30-45MIN MARK OF BYPASS. IT WAS OBSERVED THAT THE PRE-OXY PRESSURE HAD SHORT CRESCENDOS IN PRESSURE FROM OPERATIONAL PRESSURE OF ~270MMHG UP TO ~315MMHG AND BACK TO OPERATING PRESSURES. NO HEALTH CONSEQUENCES OR IMPACT . THERE WAS A DELAY; HOWEVER, THE AMOUNT OF TIME IS UNKNOWN. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY WITH ROUGHLY 20-30CC BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237061 CAPIOX FX ADVANCE HOLLOW FIBER OXYGENATOR W INTEGRATED AF W HARDSHELL RES. OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25REC 5F12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R