Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX25RWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 00699753450837), received between May 24, 2018 and Aug 7, 2026 — classified as 11 deaths, 15 injuries, 260 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (46 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 11, 2020Class IITerminated

   Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)

   Z-0565-2021 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 286 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Infusion or Flow Problem

  The user facility reported to Terumo Cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed a rapid de-priming of the venous line after pump flow was stopped. *No patient involvement.*Product was changed out.*Procedure completed successfully.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180577 ↗
• MalfunctionFeb 6, 2026Use of Device Problem

  ADDITIONAL INFORMATION INDICATES THAT THE EVENT OCCURRED DURING CARDIOPULMONARY BYPASS.

  Patient problems: Insufficient Information

  MAUDE report 24280613 ↗
• MalfunctionJan 29, 2026Air/Gas in Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING A LUNG TRANSPLANT, LARGE BUBBLES WERE COMING OUT OF THE BLOOD INFLOW SIDE OF OXYGENATOR. THE PARTIAL PRESSURE OF OXYGEN (PO2) WAS GREATER THAN 300; THE PATIENT'S SATURATION REMAINED STABLE. IT WAS ELECTED TO CHANGE THE OXYGENATOR BECAUSE THEY STILL HAD AN HOUR LEFT ON THE PUMP. PRODUCT WAS CHANGED OUT THERE WAS A 5 MINUTE DELAY IN PROCEDURE AND BLOOD LOSS OF 100CC PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212167 ↗
• MalfunctionJan 29, 2026Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE PERFUSIONIST STARTED NOTICING FOAM COMING OUT OF THE GAS OUTLET PORT AND INLET SECTION OF THE BOTTOM OF THE OXYGENATOR. THERE WAS A SLIGHT ORANGISH TINT TO IT. IT HAPPENED AT 6.5-7-HOUR MARK DURING THE PUMP RUN. THEY WERE ALREADY WARM AND GOING TO WEAN. THERE WAS DECISION MADE TO COME OFF AND TRANSITION TO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ANYWAY. NO PATIENT CARE WAS IMPACTED; GASES CONTINUED TO LOOK GOOD AND OXYGENATION WAS FINE. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS A LITTLE BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211573 ↗
• MalfunctionJan 29, 2026Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS LEAKING FLUID AND UNABLE TO OXYGENATE BLOOD ADEQUATELY ON 100% OXYGEN. THE PRODUCT WAS CHANGED OUT HOWEVER, IT IS UNKNOWN IF THERE WAS A DELAY, IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY OR IF THERE WAS ANY BLOOD LOSS. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 24210925 ↗
• MalfunctionJan 16, 2026Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, UPON REWARMING, THE PARTIAL PRESSURE OF OXYGEN (PO2) KEPT DROPPING SIGNIFICANTLY. IT WAS ALSO NOTICED THAT RED TINGED FLUID START COMING OUT THE PRIMARY AND SECONDARY EXHAUST HOLES. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY WITH UNKNOWN AMOUNT OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096689 ↗
• MalfunctionDec 11, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT POST-SURGERY AND REVERSAL OF HEPARIN, PATIENT DECOMPENSATED AND HAD TO GO BACK ON CARDIOPULMONARY BYPASS. LOADING DOSE OF HEPARIN WAS GIVEN BY ANESTHESIA (35000U HEPARIN) AND 20000U HEPARIN WAS PUT INTO THE RESERVOIR OF THE CARDIOPULMONARY BYPASS CIRCUIT. AN ACTIVATED CLOTTING TIME WAS RUN AND AS IT CONTINUED TO BE CLIMBING OVER 350 SECONDS BYPASS WAS INITIATED. FI02 WAS ON 99% WITH 2.8 LPM OF SWEEP AND THE BLOOD DID NOT PINK UP. TO RULE OUT ANY PROBLEMS WITH THE VENTILATION MODULE FOR THE QUANTUM BYPASS MACHINE THE OXYGEN LINE WAS SWITCHED OVER TO AN OXYGEN TANK AT 3LPM 100% OXYGEN. AFTER WAITING A COUPLE MINUTES, IT WAS DETERMINED THAT THE OXYGENATOR WAS NOT FUNCTIONING, SO THEY HAD TO TERMINATE CARDIOPULMONARY BYPASS AND CUT IN A NEW OXYGENATOR TO REPLACE THE NON-FUNCTIONAL ONE. THE SURGEON WAS ABLE TO REPAIR THE SURGICAL ISSUE, AND BYPASS WAS NOT RE-INITIATED. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT, PRODUCT WAS CHANGED OUT, PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WAS DELAY IN CONTINUING THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783996 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS NOT PERFORMING PROPERLY, REQUIRING INCREASING (AND EXCESSIVELY HIGH) AMOUNTS OF GAS FLOW TO VENTILATE THE PATIENT. IT IS UNKNOWN WHETHER THE PRODUCT WAS CHANGED OUT, WHETHER THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 23576115 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS NOT PERFORMING PROPERLY, REQUIRING INCREASING (AND EXCESSIVELY HIGH) AMOUNTS OF GAS FLOW TO VENTILATE THE PATIENT. IT IS UNKNOWN WHETHER THE PRODUCT WAS CHANGED OUT, WHETHER THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 23576030 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS NOT PERFORMING PROPERLY, REQUIRING INCREASING (AND EXCESSIVELY HIGH) AMOUNTS OF GAS FLOW TO VENTILATE THE PATIENT. IT IS UNKNOWN WHETHER THE PRODUCT WAS CHANGED OUT, WHETHER THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 23572950 ↗
• MalfunctionOct 30, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS NOT PERFORMING PROPERLY, REQUIRING INCREASING (AND EXCESSIVELY HIGH) AMOUNTS OF GAS FLOW TO VENTILATE THE PATIENT. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426947 ↗
• MalfunctionSep 4, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, LEAKAGE OF THE OXYGENATOR HOUSING IN THE BOTTOM SIDE WAS IDENTIFIED. CUSTOMER NOTICED INCREASING NUMBER OF BUBBLES IN THE PRIMING SOLUTION AND DECIDED TO EXCHANGE THE OXYGENATOR. NO PATIENT INVOLVEMENT PRODUCT WAS CHANGED OUT PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968506 ↗
• MalfunctionAug 11, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, A BLOOD OXYGENATION DEFECT WAS OBSERVED AT THE END OF THE OXYGENATOR OF THE EXTRACORPOREAL CIRCULATION CIRCUIT (ECC). A 64-YEAR-OLD PATIENT WAS TREATED FOR ENDOCARDITIS OF EMBOLIGENIC NATIVE MITRAL VALVE. IT IS UNKNOWN WHETHER THE PRODUCT WAS CHANGED OUT, IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776394 ↗
• MalfunctionAug 1, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, AFTER 4 HOURS, THE VENTILATION HAD TO BE INCREASED TO 10 LITERS AND OXYGEN TO 100%. THE ARTERIAL PARTIAL PRESSURE OF OXYGEN (PO2) WAS 75 MMHG. TREATMENT: BENTALL PROCEDURE. THE ENTIRE CPB SYSTEM, INCLUDING THE TUBING SET, WAS REPLACED. NO BLOOD LOSS. NO SIGNIFICANT DELAY IN PATIENT TREATMENT. THE PATIENT'S TREATMENT WAS COMPLETED AS PLANNED. *NO HEALTH CONSEQUENCES OR IMPACT. *PRODUCT WAS CHANGED OUT. *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687038 ↗
• MalfunctionJul 29, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE PARTIAL PRESSURE OF OXYGEN (PO2) STARTED DROPPING IN THE RANGE OF 100-150. THE EVENT INVOLVED A YOUNG BIG BUILT 36-YEAR-OLD PATIENT, (190CM AND 110KG) FOR AN EMERGENCY AORTIC DISSECTION, WHEREIN FLOWS OF AROUND 5.7 LITERS PER MINUTE (L/PM) AND COOLED TO 20 DEGREES. JUST AFTER THE REWARMING TO 37 DEGREES; AN AORTIC CROSS CLAMP WAS RELEASED, AND THE PARTIAL PRESSURE OF OXYGEN (PO2) STARTED DROPPING WHILE WAITING FOR REPERFUSION, RANGING FROM 100-150. THE ARTERIAL BLOOD GAS (ABG) SHOWED 130 SECONDS. AS TIME WENT BY, IT WAS STAGGERING AROUND 100-120 FOR FULL FLOWS OF 5.7 L/PM. THE FRACTION OF INSPIRED OXYGEN WAS 100% SINCE START OF REWARMING. THE PRODUCT WAS NOT CHANGED OUT, AS VENTILATION RECOMMENCED AND CONTINUOUS CLINICAL OBSERVATION. *NO HEALTH CONSEQUENCES OR IMPACT TO PATIENT *PRODUCT WAS NOT CHANGED OUT *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650353 ↗
• MalfunctionJun 13, 2025Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, HAD BUBBLE DETECTOR GO OFF STOPPING BYPASS RUN THAT REQUIRED MANIPULATIONS TO GET AIR OUT OF CIRCUIT. AS PER USER FACILITY, AFTER REMOVAL, CARDIOPULMONARY BYPASS (CPB) WAS CONTINUED FOR 5 MORE MINUTES BEFORE ANOTHER AIR ALARM. CPB WAS TEMPORARILY TERMINATED AGAIN, AND AIR WAS SEEN ON TOP OF THE OXYGENATOR. WHEN PERFUSIONIST OPENED PURGE LINE, THE AIR WENT DOWN INSTEAD OF UP. THE PATIENT ARTERIAL LINE WAS CLAMPED AT THE FIELD AND AGAIN AIR REQUIRED REMOVAL BY SURGEON AT THE POINT OF LUER-LOCK ON THE CANNULA. AFTER THE AIR WAS REMOVED CPB WAS REINSTITUTED WITHOUT INCIDENT FOR THE REMAINDER OF THE PROCEDURE. DELAY WAS 5 MINUTES DURING THE BYPASS RUN IN WHICH THE PATIENT HAD NO PERFUSION. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS NOT CHANGED OUT. THERE WAS A MINIMAL AMOUNT OF BLOOD LOSS WHILE DE-AIRING THE ARTERIAL LINE. PROCEDURE COMPLETED SUCCESSFULLY WITH 5 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205929 ↗
• MalfunctionJun 2, 2025Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR DISLODGED AN AIR BUBBLE. THERE WAS A VISIBLE AIR BUBBLES SEEN IN LINE, TRIPPED THE AIR BUBBLE DETECTOR AND THE PUMP STOPPED. SMALL SERIES OF POPPY SEED SIZE BUBBLES - COLLECTIVELY 20 CENT PIECE SIZE. THEY MANAGED TO REMOVE THE AIR. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. *PRODUCT WAS NOT CHANGED OUT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122401 ↗
• MalfunctionMar 28, 2025Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A RISE OF AIR BUBBLE IN VENOUS RESERVOIR. AS PER USER FACILITY, WHEN RECIRCULATING THE PRIMING VOLUME DURING PREPARATION, THEY NOTICED A SIGNIFICANT RISE OF AIR BUBBLES IN THE VENOUS RESERVOIR, JUST BEFORE THE OUTLET TO THE ARTERIAL PUMP. WHEN THE ARTERIAL PUMP WAS STOPPED, A CONSIDERABLE AMOUNT OF AIR BUBBLES ROSE TOWARDS THE VENOUS INLET. ALL 3-WAY STOPCOCKS IN THE VENOUS ACCESS WAS REPLACED TO RULE OUT THE ERROR. NO PATIENT INVOLVEMENT, PRODUCT WAS CHANGED OUT, PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720607 ↗
• MalfunctionMar 14, 2025Decrease in Pressure; Low Readings; Decrease in Pressure; Low Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE PARTIAL PRESSURE OF OXYGEN (PO2) ON THE OXYGENATOR BEGAN TO DROP RAPIDLY. AS PER USER FACILITY, DURING PROCEDURE, AROUND REWARMING, THE PARTIAL PRESSURE OF OXYGEN (PO2) ON THE OXYGENATOR BEGAN TO DROP RAPIDLY, SO THE PERFUSION PRIMED ANOTHER OXYGENATOR IN PREPARATION. RUNNING ON PO2S OF ABOUT 600MMHG (MILLIMETERS OF MERCURY). THE NEW OXYGENATOR WAS CUT INTO THE PRONTO LINE WHEN THE PO2 WAS ABOUT 180MMHG ON 100% OXYGEN. THIS FIXED THE PROBLEM, AND THE PO2 BEGAN TO RISE AND RETURNED BACK TO EXPECTATIONS, AND BOTH OXYGENATORS WERE RUNNING AT THE END. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY WITH 5 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610004 ↗
• MalfunctionMar 14, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR'S PRESSURE INCREASED, GRADUALLY DECREASING. IT IS UNKNOWN WHETHER THERE WAS A DELAY, WHETHER THE SURGERY WAS COMPLETED AND IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. REPLACEMENT WAS UNNECESSARY, AND THERE WAS NO IMPACT ON PATIENT PRESSURE OR OXYGENATION. IMMEDIATE ACTION THAT WAS TAKEN: ACT WAS MEASURED AND FOUND TO BE WITHIN THE TARGET RANGE, BUT 10,000 IU OF HEPARIN WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 21608102 ↗
• DeathFeb 21, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS A POSSIBLE OXYGENATOR FAILURE OCCURRED. ADDITIONALLY, THE PROCEDURE WAS FOR A BILATERAL LEFT VENTRICULAR ASSISTANCE DEVICE INSERTION. THE OXYGENATOR PRODUCED PAOS PREDOMINANTLY IN THE LOW TO MID 200S WITH FRACTION OF INSPIRED OXYGEN (FIO2S) GRADUALLY INCREASING FROM 70 TO 100%, FLOWING FROM 4.5-5 L/MIN. BLOOD GASES, HEAD SATS, AND CDI MEASUREMENTS SUPPORTED THAT THE PATIENT WAS ADEQUATELY PERFUSED. THE PATIENT, UNFORTUNATELY, HAD A BAD OUTCOME, AND PASSED SHORTLY AFTER THE PROCEDURE. SURGEON DISCUSSED WITH PERFUSION AND ANESTHESIA, AND IT WAS THE SURGEON'S OPINION THAT THE OXYGEN WAS NOT PROPERLY OXYGENATING THE PATIENT. PERFUSION DID NOT AGREE WITH THIS ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435369 ↗
• MalfunctionFeb 20, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR STARTED TO FAIL 320 MINUTES INTO THE BYPASS RUN. THE PRODUCT WAS NOT CHANGED OUT AS AN ADDITIONAL OXYGENATOR WAS ADDED. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426795 ↗
• DeathNov 27, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION OBTAINED FROM THE CLINICAL SPECIALIST. A FOLLOW-UP PHONE INTERVIEW WAS CONDUCTED, AND SOME DETAILS WERE SHARED WITH TERUMO. THIS PATIENT WAS VERY SICK AND ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) BYPASS BEFORE THE SURGERY. THE SURGERY WAS A DOUBLE LUNG TRANSPLANT THAT WAS ON CARDIOPULMONARY BYPASS FOR NEARLY 7 HOURS WITH THE FX25 OXYGENATOR. THE FX25 OXYGENATOR IS RATED FOR 6 HOURS OF USE ONLY. THE PATIENT CRASHED ONTO EMERGENCY BYPASS AFTER THE SURGEON UNEXPECTEDLY CUT INTO A BLOOD VESSEL. THE FIRST ACTIVATED CLOTTING TIME (ACT) VALUE EVALUATING ANTI-COAGULATION WAS OVER 1000 SECONDS. DURING THE PERIOD OF THE OXYGENATION PERFORMANCE ISSUES, THE ACT VALUES WERE IN THE 600S SECONDS RANGE. THESE VALUES ARE ADEQUATE VALUES DURING BYPASS IN TERMS OF HEPARINIZATION, BUT DO NOT REVEAL THE BLOOD CONCENTRATION OF HEPARIN, AS WHEN A HEPCON DEVICE IS USED, WHICH WOULD HAVE GIVEN THE CLINICIAN A MORE ACCURATE ASSESSMENT OF ANTI-COAGULATION STATUS. THE OXYGENATION PARTIAL PRESSURE OF OXYGEN (PO2) VALUES DURING THE PERFORMANCE ISSUES WERE OBSERVED TO BE IN THE LOW 100S MMHG AND THEN FALLING INTO THE 60S MMHG. AN ADDITIONAL OXYGENATOR WAS INSERTED INTO THE RECIRCULATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800423 ↗
• MalfunctionNov 26, 2024Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE CENTER OF THE YELLOW LUER CAP BROKE OFF IN THE RIGHT-SIDE PORT OF THE MANIFOLD. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780671 ↗
• MalfunctionNov 26, 2024Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE CENTER OF THE YELLOW LUER CAP BROKE OFF IN THE RIGHT-SIDE PORT OF THE MANIFOLD. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778890 ↗