BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX HOLLOW FIBER OXYGENATOR W INTEGRATED ARTERIAL FILTER W HARDSHELL RES.

    MDR report key: 23876218 · Received December 23, 2025

    Report

    Report Number
    1124841-2025-00115
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 28, 2025
    Report Date
    March 17, 2026
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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.

    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 DECEMBER 23, 2025. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: G3 (DATE RECEIVED BY MANUFACTURER). G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT). H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION). H6 (IDENTIFICATION OF EVALUATION CODES 11, 3331, 4114, 3221, 4315). THE AFFECTED SAMPLE WAS NOT RETURNED FOR EVALUATION; HOWEVER, A PHOTO WAS PROVIDED THAT SHOWS A CLOT AROUND THE FILTER. A REPRESENTATIVE RETENTION SAMPLE FROM THE SAME PRODUCT LOT NUMBER WAS OBTAINED AND TESTED. THE RETENTION SAMPLE WAS TESTED FOR CR BREAK THROUGH TIME, BREAK THROUGH VOLUME, AND STATIC VOLUME. ALL RESULTS WERE WITHIN SPECIFICATIONS. WITHOUT THE RETURN OF THE ACTUAL SAMPLE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS, THAT WHEN DISASSEMBLING THE TUBING PACK AT THE END OF THE EXTRACORPOREAL CIRCULATION, IT WAS REALIZED THAT THERE WAS A BIG CLOT AROUND THE FILTER OF THE RESERVOIR. THE CASE WAS ABLE TO BE FINISHED SUCCESSFULLY (ADULT PATIENT). THE ACT WAS ABOVE 480 DURING THE PROCEDURE. IT WAS AN INTERVENTION WITH ROBOT. PER THE CUSTOMER: IT IS BEING INVESTIGATED TO SEE IF THERE IS ANY AGREEMENT IN TERMS OF PREVIOUS TREATMENTS OF THE PATIENT, INTRA OPERATIVE PHARMACOLOGICAL MANAGEMENT. IT IS ALSO BEING INVESTIGATED AS TO WHAT PREVIOUS COAGULATION TESTS THE PATIENT HAD. *NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. *PRODUCT WAS NOT CHANGED OUT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311329 CAPIOX FX HOLLOW FIBER OXYGENATOR W INTEGRATED ARTERIAL FILTER W HARDSHELL RES. OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ*FX25RECA 4N18

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown