Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX15RW30CRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00699753450783), received between Sep 14, 2018 and Jan 13, 2026 — classified as 3 deaths, 4 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Increase in Pressure

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, HIGH PRESSURE WAS OBSERVED IN THE SYSTEM WITHOUT VISIBLE KINKING OF THE TUBING OR OTHER VISIBLE OBSTRUCTIONS. THE PRESSURE WAS MEASURED BEFORE AND AFTER THE OXYGENATOR, WHICH WAS EQUALLY HIGH AT BOTH POSITIONS. FURTHER INVESTIGATION, AT THE USER FACILITY, LED TO THE CONCLUSION THAT THERE WAS AN OBSTRUCTION IN THE VENOUS RESERVOIR. THE SURGICAL PROCEDURE WAS TEMPORARILY SUSPENDED UNTIL THE PROBLEM WAS RESOLVED BY REPLACING THE SET WITH A NEW ONE. NO PATIENT INVOLVEMENT PRODUCT WAS CHANGED OUT PROCEDURE COMPLETED SUCCESSFULLY WITH 15-20 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051317 ↗
• MalfunctionSep 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE PATIENT REACTED STRONGLY TO THE FOREIGN SURFACE. AS PER THE USER FACILITY, THE HEART-LUNG MACHINE (HLM) AND OXYGENATOR WERE FILLED AND PREPARED AS USUAL. DURING THE SURGERY, THE PATIENT WAS CONNECTED TO THE MACHINE HEART LUNG MACHINE IN THE STANDARD MANNER. IMMEDIATELY AFTER STARTING THE BYPASS, THE PATIENT REACTED STRONGLY TO THE FOREIGN SURFACE. FOR SEVERAL MINUTES, THERE WERE ISSUES WITH THE PATIENT'S BLOOD PRESSURE. THE PRESSURE GRADIENT IN THE OXYGENATOR ALSO INCREASED IN PARALLEL. AN INTERDISCIPLINARY TEAM (SURGEON, ANESTHESIOLOGIST, AND PERFUSIONIST) DECIDED ON THE FOLLOWING PROCEDURE. THE PATIENT WAS GIVEN A HIGH DOSE OF CORTISONE. AT THE SAME TIME, THE BYPASS WAS INTERRUPTED, AND THE PATIENT WAS TAKEN OFF THE MACHINE AGAIN. THE OXYGENATOR WAS CHANGED FROM FX15RW30C TO FX25RWC AT 11:08:30; CONTINUATION AT 11:08:50 ACCORDING TO THE PERFUSION PROTOCOL, CALMLY AND WITHOUT TIME PRESSURE. THE BYPASS WAS THEN RESTARTED WITH THE FX25RWC OXYGENATOR. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. THERE WAS AN UNKNOWN AMOUNT OF DELAY. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095708 ↗
• MalfunctionAug 11, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A PINK FLUID COMING OUT OF BOTH SIDES OF THE GAS PORTS. THIS WAS AN ADULT CASE THAT STARTED (B)(6) EVENING AND ENDED AT 5 AM (B)(6). PATIENT = 89 KG, AVERAGE FLOW = 4.5 L/MIN, LINE PRESSURE = 215-230 MOST OF THE TIME, MEAN ARTERIAL PRESSURE (MAP) = 50¿S, SWEEP RATE = 2.3-3 MOST OF THE TIME, ACTIVATED CLOTTING TIME (ACT) = 1000+ THE ENTIRE CASE, BYPASS TIME = 351 MINUTES. PATIENT WAS NOT DOING GREAT DURING THE CASE BECAUSE THEY HAD RECEIVED CARDIOPULMONARY RESUSCITATION (CPR) FOR 45 MIN PRIOR TO GOING INTO THE OPERATING ROOM. PATIENT WAS ALSO PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND THEN TRANSITIONED TO BYPASS 20 MIN LATER. LOWEST LACTATE WAS 15 TO START. PINK FLUID NOT NOTICED UNTIL THE END OF THE CASE, WHEN THEY CAME OFF BYPASS AND OXYGENATION WAS GOOD THE ENTIRE PROCEDURE. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT, PRODUCT WAS NOT CHANGED OUT, THERE WAS A BLOOD LOSS OF 5CC, PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770142 ↗
• MalfunctionJun 13, 2025Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR HAD AIR BUBBLES WHICH STOPPED THE PUMP. AS PER THE SUBSIDIARY, THE OXYGENATOR WAS BEING USED FOR STRAIGHTFORWARD CORONARY ARTERY BYPASS GRAFTING. PRIMING WAS UNEVENTFUL WITH PLASMA-LYTE AND 20% ALBUMEN; "SMALL TUBING CIRCUIT" USED AS PATIENT BODY SURFACE AREA < 1.8. PRIMING GAS CONFIRMED PARTIAL PRESSURE OF OXYGEN (PO2) > 550. THE ACTIVATED CLOTTING TIME (ACT) 776 SEC AFTER HEPARIN. ARTERIAL LINE PLACED BY SURGEON, LINE PRESSURES CHECKED, AND EQUAL TO MEAN ARTERIAL PRESSURE (MAP). RIGHT ATRIAL PRESSURE (RAP) PERFORMED. THE VENOUS LINE WAS PLACED BY A SURGEON. "ON BYPASS" WITH VAP PERFORMED. SEVOFLURANE STARTED. SOME LOW FLOWS - VENOUS OCCLUDER FULLY OPENED. CARDIOPLEGIA LINE PRIMED. FLOWS DOWN FOR CROSS-CLAMP PLACEMENT. ANTEROGRADE AORTIC ROOT HYPERKALEMIA BLOOD CARDIOPLEGIA RUN, GOOD PRESSURE RESPONSE. 3 MINUTES INTO PLEGIA, "ARTERIAL AIR ALARM" AND PUMP STOPPED. PERFUSIONIST INSPECTED ARTERIAL LINE - AIR VISIBLE JUST DISTAL TO BUBBLE DEVICE. ARTERIAL LINE CLAMPED ON PATIENT SIDE OF AIR. RECIRCULATION LINE OPENED, ARTERIAL LINE BRIEFLY OPENED TO ALLOW BACK FLOW. ARTERIAL LINE REC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206161 ↗
• MalfunctionMay 16, 2025Leak/Splash; Leak/Splash

  NEW INFORMATION RECEIVED, THERE WAS NO BLOOD LOSS.

  Patient problems: Insufficient Information

  MAUDE report 22035087 ↗
• MalfunctionMar 28, 2025Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THEY NOTICED HIGH PRESSURE ON THE VENOUS LINE. AS PER USER FACILITY, IT WAS EVIDENT WHEN THEY TRIED TO PUSH HEPARIN THROUGH THE MANIFOLD AND THE BACK PRESSURE STARTED FILLING THE SYRINGE. IT WAS FURTHER CONFIRMED BY DISCONNECTING THE CONNECTION BETWEEN MANIFOLD AND VENOUS LINE (LEUR CONNECTION TWO INCHES OF THE VENOUS LINE). IT WAS CHANGED, AND FOUND DURING INSPECTION THAT THE VENOUS LINE ON THE INSIDE OF THE RESERVOIR WAS KINKED. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718724 ↗
• MalfunctionFeb 20, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR FAILED AFTER 240 MINUTES ON BYPASS. AS PER USER FACILITY, PARTIAL PRESSURE OF OXYGEN (PAO2) DROPPED INTO THE 50'S. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426712 ↗
• MalfunctionAug 12, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR DURING CARDIOPULMONARY BYPASS, THEY NOTICED PLASMA LEAK. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19964595 ↗
• MalfunctionApr 23, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR'S PH STARTED DROPPING AND PCO2 RISING. THE CASE WAS FOR A HEART TRANSPLANT WITH A TOTAL BYPASS TIME OF APPROXIMATELY 2 HOURS, WITH NO PROBLEM ON THE FIRST HOUR. THE PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) STARTED CLIMBING SLOWLY, AND WHEN IT REACHED ABOUT 8 KILOPASCAL (KPA), THE PH STARTED DROPPING. THERE WERE NO ALTERATIONS IN FLOW, PRESSURE OR OXYGENATION, AND THE PARTIAL PRESSURE OF OXYGEN (PO2), AND SATURATION WERE ALSO WITHIN THE NORMAL RANGE AND UNAFFECTED. THEY RAN A MAXIMUM SWEEP GAS OF 5L/MIN, AS THEIR GAS MIXER ON THE PEDIATRIC MACHINE WAS LIMITED TO 5L/MIN. THE ACT WAS >480 SECONDS, AND HEPCON WAS AT > 3.5. THEY COULD COME OFF BYPASS WITH THE PH AT 7.1 AND PCO2 AT 9KPCL; HOWEVER, THE PATIENT WAS A BIT UNSTABLE; THEREFORE, THEY WERE NOT ABLE TO COME BACK ON BYPASS. WHEN THEY STARTED VENTILATING THE PATIENT'S OWN LUNGS, HE QUICKLY RECOVERED. HIS LACTATE LEVELS WERE LOW ALL THE TIME, AND THE PATIENT'S CONDITION IS FINE. NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162835 ↗
• DeathApr 4, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION FROM THE CLINICAL SPECIALIST INDICATES THAT BASED ON THE LIMITED DETAILS PROVIDED ABOUT THE PUMP RUN. THE PATIENT WAS A 9 YEAR OLD CHILD UNDERGOING CONGENITAL DEFECT HEART SURGERY. AFTER INITIATION OF BYPASS, A BLOOD FLOW OF 2.2 LPM WAS ACHIEVED WITH A SWEEP GAS RATE OF 1.4 LPM AT 70 PERCENT FRACTION OF INSPIRED OXYGEN (FIO2). THE BLOOD GASES REVEALED A PARTIAL PRESSURE OF OXYGEN (PO2) OF 462 MMHG AND AN ACTIVATING CLOTTING TIME (ACT) OF 698 SECONDS AT THIS POINT. APPROXIMATELY 2 AND A HALF HOURS INTO THE BYPASS RUN THE PO2 DECREASED TO 52.7MMHG, AND THE GAS SWEEP WAS INCREASED TO 3LPM AT 100 PERCENT FIO2. THE ACT AT THIS POINT WAS MEASURED TO BE 360 SECONDS AND HEPARIN WAS GIVEN. AFTER CHECKING OXYGEN SOURCE, THE GAS BLENDER ON THE HEART LUNG MACHINE WAS CHANGED OUT TO NO EFFECT. THE GAS SOURCE WAS THEN CHANGED TO AN OXYGEN CYLINDER TO NO EFFECT. IT WAS DECIDED TO CHANGE OUT THE OXYGENATOR, AFTER WHICH OXYGENATION DID IMPROVE. THE IFU FOR THE TERUMO FX15 STATES TO START BYPASS AT A GAS FLOW SWEEP OF 1 TO 1 WITH THE BLOOD FLOWRATE AND A FIO2 OF 100 PERCENT OXYGEN. THE CLINICIAN IN THIS COMPLAINT DID NOT DO THIS. IT IS POSSIBLE TO FALL BEHIND OXYGENATION WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047123 ↗
• MalfunctionJan 29, 2024Connection Problem; Connection Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SET UP, THE DRUG PORT CONNECTOR HAS NOT BEEN GLUED. *NO PATIENT INVOLVEMENT *PRODUCT WAS CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602433 ↗
• InjuryJan 12, 2024Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A DEFECT IN THE OXYGENATOR CAUSING EXCESSIVE FLOW RESISTANCE. AS PER THE LEAD PERFUSIONIST, HE EXPERIENCE THE CLINICAL PRESENTATIONS OF AN OXYGENATOR FAILURE. UPON INITIATING BYPASS, LINE PRESSURE, FLOW RATE, AND RPM'S, THEY WERE WITHIN NORMAL RANGE. AFTER ROUGHLY 3-4 MINUTES HE NOTICED A CONSISTENT DECREASE IN ARTERIAL LINE PRESSURE AND FLOW RATE WHICH REQUIRED AN INCREASE IN RPM'S TO MAINTAIN NORMAL FLOWS. AT THIS POINT, HE CONFIRMED THERE WERE NO OPEN SHUNTS WITHIN THE CIRCUIT. ADDITIONALLY, HE FELT THAT THE OXYGENATOR INLET LINE WAS HIGHLY PRESSURIZED. BY THE TIME THEY MADE THE DECISION TO CHANGE THE OXYGENATOR, THE RPM'S WERE NEARLY MAXED OUT AROUND 3500-3700 WITH A SUBSEQUENT FLOW RATE OF 2.6 LPM. THE ACT WAS IN THERAPEUTIC RANGE, LEADING THEM TO BELIEVE THAT THERE WAS A DEFECT IN THE OXYGENATOR FIBERS CAUSING EXCESSIVE FLOW RESISTANCE. THERE WAS A DELAY, AS THE CHANGEOUT LASTED APPROXIMATELY 3 MINUTES WHILE THE PATIENT TEMPERATURE WAS 30 DEGREES CELSIUS. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. *THERE WAS A BLOOD LOSS FOR APPROXIMATELY 250 ML*PROCEDURE WAS COMPLETED SUCCESSF

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18505519 ↗
• MalfunctionNov 7, 2023Break; Break

  BROKEN RECIRC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18087677 ↗
• MalfunctionNov 1, 2023Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THEY NOTICED THAT THE CAPS ON THE SAMPLING MANIFOLD WERE BROKEN. NO PATIENT INVOLVEMENT; PRODUCT WAS CHANGED OUT; PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046468 ↗
• MalfunctionOct 6, 2023Use of Device Problem; Use of Device Problem

  OXYGENATOR FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890164 ↗
• DeathOct 6, 2023Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION FROM THE CLINICAL SPECIALIST DURING HIS PHONE INTERVIEW BETWEEN HIM, THE SALES AND THE CUSTOMER STATES THAT THIS CASE INVOLVED A PATIENT WITH A BSA OF 1.82M2, WITH HEART FAILURE AND HAD BEEN PLACED ON ECMO. THE PATIENT UNDERWENT A HEART TRANSPLANT THAT WAS REJECTED AND WAS PLACED ON ECMO. THE PATIENT THEN DEVELOPED LIVER FAILURE. THE OXYGENATORS IN THESE COMPLAINTS WERE USED DURING A SECOND HEART TRANSPLANT FOR THIS PATIENT. THE PATIENT DIED OF AN INTER-CRANIAL BLEED ON THE SECOND DAY POST-OPERATIVELY. THIS WAS A CRITICALLY ILL PATIENT WITH A HIGH MORBIDITY OUTCOME. THE PUMP RUN WAS 192 MINUTES LONG. THE FIRST BLOOD GAS WAS: PH 7.38, PCO2 47MMHG AND PO2 418MMHG. THE FIRST ACT ON PUMP WAS OVER 600 SECONDS AFTER 17,000 IU OF HEPARIN, WITH AN ISTAT DEVICE. NO HEPCON DEVICE WAS USED. THE PATIENT WAS COOLED TO 32 DEGREESC. APPROXIMATELY 45 MINUTES INTO THE PUMP RUN, THE PO2 DECREASED FROM 200MMHG TO 130MMHG IN 5 MINUTES, EVEN THOUGH THE FIO2 WAS INCREASED FROM 70% TO 100%. THE ACT AT THIS POINT WAS 536 SECONDS. THIS WAS THE LOWEST ACT FOR THE CASE. THE PATIENT WOULD EVENTUALLY RECEIVE 10,000 IU OF HEPARIN FOR THE PUMP RUN, IN ADDITION TO THE INITIAL 17,000 IU PRE-

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17886094 ↗
• DeathOct 6, 2023Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION FROM THE CLINICAL SPECIALIST DURING HIS PHONE INTERVIEW BETWEEN HIM, THE SALES AND THE CUSTOMER STATES THAT THIS CASE INVOLVED A PATIENT WITH A BSA OF 1.82M2, WITH HEART FAILURE AND HAD BEEN PLACED ON ECMO. THE PATIENT UNDERWENT A HEART TRANSPLANT THAT WAS REJECTED AND WAS PLACED ON ECMO. THE PATIENT THEN DEVELOPED LIVER FAILURE. THE OXYGENATORS IN THESE COMPLAINTS WERE USED DURING A SECOND HEART TRANSPLANT FOR THIS PATIENT. THE PATIENT DIED OF AN INTER-CRANIAL BLEED ON THE SECOND DAY POST-OPERATIVELY. THIS WAS A CRITICALLY ILL PATIENT WITH A HIGH MORBIDITY OUTCOME. THE PUMP RUN WAS 192 MINUTES LONG. THE FIRST BLOOD GAS WAS: PH 7.38, PCO2 47MMHG AND PO2 418MMHG. THE FIRST ACT ON PUMP WAS OVER 600 SECONDS AFTER 17,000 IU OF HEPARIN, WITH AN ISTAT DEVICE. NO HEPCON DEVICE WAS USED. THE PATIENT WAS COOLED TO 32 DEGREES C. APPROXIMATELY 45 MINUTES INTO THE PUMP RUN, THE PO2 DECREASED FROM 200MMHG TO 130MMHG IN 5 MINUTES, EVEN THOUGH THE FIO2 WAS INCREASED FROM 70% TO 100%. THE ACT AT THIS POINT WAS 536 SECONDS. THIS WAS THE LOWEST ACT FOR THE CASE. THE PATIENT WOULD EVENTUALLY RECEIVE 10,000 IU OF HEPARIN FOR THE PUMP RUN, IN ADDITION TO THE INITIAL 17,000 IU PRE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17886043 ↗
• MalfunctionSep 15, 2023Break; Break

  BROKEN VENOUS INLET TEMP PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759937 ↗
• MalfunctionJul 6, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  INCORRECT PRODUCT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265384 ↗
• MalfunctionJun 23, 2023Unintended Movement; Unintended Movement

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE VENOUS INLET THERMISTOR WAS LOOSEN. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190248 ↗
• MalfunctionJun 23, 2023Unintended Movement; Unintended Movement

  LOOSE VENOUS INLET THERMISTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190221 ↗
• MalfunctionJun 23, 2023Defective Component; Unintended Movement; Defective Component; Unintended Movement

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED A LOOSE VENOUS INLET THERMISTOR. NO KNOWN HEALTH CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190198 ↗
• InjuryMay 5, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR FAILED TO THE FULL EXTENT. PER SUBSIDIARY, THERE WAS NO COLOR CHANGE IN THE ARTERIAL LINE AFTER THE HLM HAD STARTED. AFTER 5 MINUTES, GAS CALIBRATION CONFIRMED THE SUSPICION OF AN OXYGENATOR FAILURE. PATIENT'S YEAR OF BIRTH: (B)(6). THE CONTINUATION OF THE PROCEDURE WAS DELAYED BY 5 MINUTES. THERE WAS APPROXIMATELY 300 ML BLOOD LOSS. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16876660 ↗
• MalfunctionApr 14, 2023Use of Device Problem; Use of Device Problem

  OXYGENATOR DID NOT OXYGENATE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741934 ↗
• MalfunctionJan 3, 2023Break; Break

  ADDITIONAL INFORMATION INDICATES THAT THE PRODUCT WAS CHANGED OUT.

  Patient problems: Insufficient Information

  MAUDE report 16091209 ↗