BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24619216 · Received March 17, 2026

    Report

    Report Number
    1124841-2026-00027
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 19, 2026
    Report Date
    May 29, 2026
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TERUMO WILL NOT RECEIVE THE DEVICE FOR EVALUATION; HOWEVER, 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. THE PRODUCT BEING REPORTED DOES NOT HAVE A PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER ASSOCIATED AS IT IS NON-STERILE AND IS INTENDED FOR FURTHER PROCESSING INTO CONVENIENCE KITS. NON-STERILE PRODUCTS ARE SUBSEQUENTLY STERILIZED ONCE INCORPORATED INTO A CONVENIENCE KIT. NON-STERILE PRODUCT IS AT NO TIME INTRODUCED INTO COMMERCIAL DISTRIBUTION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, WITH A PLANNED BLOOD FLOW OF 6.5 LPM (DUE THE BMI) AND A GAS FLOW AT THE END OF EXTRACORPOREAL CIRCULATION (ECC) OF 10 LPM. TOWARDS THE END OF THE ECC (LENGTH 149 MIN) CONDENSATE ACCUMULATES IN THE OXYGENATOR CHAMBER, AND THE WATER LEVEL REACHES THE WHITE POROUS PART INSIDE. THE OXYGENATOR WAS FULL OF WATER UP TO THE SIDE OUTLET. A LARGE DROP OF WATER FILLED THE ENTIRE OUTFLOW / BLOCKED OUTFLOW. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143832 CAPIOX FX ADVANCE HOLLOW FIBER OXYGENATOR W INTEGRATED AF W HARDSHELL RES. OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ*FX25RECA 4L23

    Patients

    Seq Age Sex Outcome Treatment
    1