BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20993689 · Received December 20, 2024

    Report

    Report Number
    1124841-2024-00129
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 26, 2024
    Report Date
    March 17, 2025
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K151389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 DECEMBER 20, 2024. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D4 (ADDED LOT NUMBER AND EXPIRATION DATE) G3 (DATE RECEIVED BY MANUFACTURER) G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT) H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION) H4 (ADDED MANUFACTURING DATE) 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. A MANUFACTURING AND INCOMING INSPECTION RECORDS OF POTENTIAL LOT NUMBERS WERE FOUND TO HAVE NO ANOMALIES. THE DEVICE BEING REPORTED WAS BUILT IN A TUBING PACK AND ACCORDING TO THE DEVICE HISTORY RECORD, THERE ARE 2 POTENTIAL OXYGENATOR LOT NUMBERS. WITHOUT RECEIVING THE ACTUAL DEVICE, THE EXACT LOT NUMBER CANNOT BE IDENTIFIED. THEREFORE, ONE POTENTIAL LOT INFORMATION HAS BEEN INPUT IN D4 AND H4, THE OTHER POTENTIAL LOT INFORMATION IS LISTED HERE: 3ZZ*FX15RE30CA LOT 3H24 DOM: (B)(6) 2023 EXP: 06/30/2026. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    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, THE PERFORMANCE OF THE TUBING PACK WITH OXYGENATOR IS LOWER THAN USUAL. THE READINGS WERE NOT NORMAL. BEFORE, WITH THE SAME FLOW RATE THEY COULD EASILY GET UP TO 5 LITERS (L) AND WITH THIS CASE THE MAXIMUM WAS 4,05L. IT IS UNKNOWN IF THERE WAS A DELAY, IF THE PRODUCT WAS CHANGED OUT, IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND IF THE PRODUCT CAUSE OR CONTRIBUTED TO AN INJURY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375751 CAPIOX FX ADVANCE HOLLOW FIBER OXYGENATOR W INTEGRATED AF W HARDSHELL RES. OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ*FX15RE30CA 3H17

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown