Capiox RX Hollow Fiber Oxygenator with Hardshell ReservoirRecalls & reported problems across all models

We found 6 models of Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir by Terumo Cardiovascular Systems Corporation in the FDA's device registry (GUDID). Together they are named in 99 adverse event reports in the FDA's MAUDE database, received between Nov 19, 2015 and Jun 10, 2024 — classified as 1 death, 6 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (29 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 1, 2023Class IIOpen, Classified

   Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

   Z-1345-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir problems

Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RE30

  Oxygenator, Cardiopulmonary Bypass
  1 recall16 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX25RW

  Oxygenator, Cardiopulmonary Bypass
  39 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX25RE

  Oxygenator, Cardiopulmonary Bypass
  1 death24 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RE40

  Oxygenator, Cardiopulmonary Bypass
  11 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RW30

  Oxygenator, Cardiopulmonary Bypass
  5 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RW40

  Oxygenator, Cardiopulmonary Bypass
  4 reports

Recent Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXY IN LINE BLEW OFF WHILE ON PUMP. *THERE WAS A BLOOD LOSS OF 1500CC *PRODUCT WAS CHANGED OUT *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19505099 ↗
• MalfunctionSep 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NON-CONFORMING LABELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17830375 ↗
• MalfunctionJun 7, 2023Break; Break

  MANIFOLD CAPS WERE ALL BROKEN AT THE TOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079312 ↗
• MalfunctionJun 5, 2023Leak/Splash; Leak/Splash

  LEAKING PLASMA CREATING WHITE FOAM FROM THE GAS OUTLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061986 ↗
• InjuryMar 14, 2023Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED BY THE CLINICAL SPECIALIST, FROM THE CHIEF OF PERFUSION STATES THAT, THE CDI550 WAS CALIBRATED AND LAB BLOOD GAS WAS CHECKED THROUGH ISTAT, AND THEY DO NOT FOLLOW DO2S AND VO2S. THE PATIENT WAS CANULATED SPLIT ARTERIAL, ONE TO THE LEG, AND ONE TO THE UPPER BODY; THIS WAS A TYPE 2 THORACOABDOMINAL ANEURYSM. THEY NOTICED THE CHANGE IN THE OXYGENATOR UPON REWARMING. ANOTHER INDICATIONS THAT THERE WERE CHANGES IN THE PATIENT HEMODYNAMICS WERE; WHEN SHE WAS CALLED TO HELP THE PERFUSIONIST DOING THE CASE; AS THE HEMATOCRITS WERE LOW AT 20, THE CEREBRAL SATURATIONS WERE 19 AND THE FLOW TO THE PATIENT WAS LOW, 1 LITER TO THE LEG, AND 2 LITERS TO THE UPPER BODY. THIS IS DICTATED BY THE SURGEON AND DEPENDING ON WHERE HE IS ON THE PROCEDURE. THE ANTICOAGULATION WAS GOOD; ACT¿S ABOVE 1000 THROUGHOUT THE CASE, UNTIL THEY CHANGED OUT THE OXYGENATOR. THEN THEY WERE IN THE 600-700¿S. THEY HAD NO ISSUES WITH ANY OTHER CARDIAC CASES BESIDES THE THORACOABDOMINAL CASES, EVEN WITH ASCENDING DISSECTIONS WITH CIRCULATORY ARREST; FOR THIS IS A 20-YEAR PROGRAM AT THE IU METHODIST. THEY ALSO DID NOT TAKE ANY PVO2 LAB MEASUREMENTS, AND THERE WAS NO DIFFERENCE HAPPENING DURING

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16537190 ↗
• MalfunctionMar 14, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE ARTERIAL PO2 WAS IN NORMAL LEVELS WITH ARTERIAL BLOOD SAMPLES. AS PER SUBSIDIARY. THE PATIENT WAS UNDERGOING CARDIAC SURGERY PRESENTS A CHANGE IN THE COLORATION OF THE BLOOD, TAKING ON A DARK COLOR, WHICH INDICATES TO THE PERFUSIONIST THAT OXYGENATION LEVELS ARE LOW. THE ABOVE OCCURS AT THE MOMENT OF ENTERING THE PUMP. THE PATIENT REGAINED LEVELS OF OXYGENATION AND IN NORMAL CONDITION. *NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536559 ↗
• MalfunctionFeb 23, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE BLOOD BECOMES DARK IN COLOR AND THE PO2 DECREASES FROM 415 MMHG TO 182MMHG. PER FACILITY, THE PERFUSIONIST REPORTS THAT DURING THE MITRAL VALVE REPLACEMENT PROCEDURE, THE BLOOD BECOMES DARK IN COLOR AND THE PO2 DECREASES FROM 415 MMHG TO 182 MMHG. THE BIOMEDICAL ENGINEER CHECKS THE OXYGEN LEVELS IN THE BLENDER AND VAPORIZER AND FINDS THAT THEY ARE WITHIN NORMAL RANGE, BUT THE DARK COLORING IN THE BLOOD AND LOW OXYGEN INDICES ARE PRESENT. DURING THE PROCEDURE, A SATISFACTORY SATURATION IS ACHIEVED, BUT WHEN THE DEVICES ARE USED AT THEIR LIMITS (BLENDER AND VAPORIZER WITH FIO2 AT 100% AND OXYGEN FLOW OF 4.8 LITERS), THE DARK COLORING AND LOW INDICES PERSIST. NO KNOWN IMPACT OR CONSEQUENCES TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427405 ↗
• MalfunctionFeb 3, 2023Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION FROM THE CLINICAL SPECIALIST, BASED ON THE CONDUCTED PHONE INTERVIEW WITH THE PERFUSIONIST STATES THAT, THE PERFORMANCE AND CHANGE OUT OF THE OXYGENATOR WAS NOT A CAUSE OF THE PATIENT REQUIRING ECMO AT THE END OF THIS VERY LONG, COMPLICATED CASE. THE PATIENT WAS VERY SICK AND WITH A HIGH RISK FOR SURGERY. WHEN ASKED ABOUT THE ANTI-COAGULATION MANAGEMENT OF THE PATIENT, THE PERFUSIONIST VERBALLY COMMUNICATED THAT NUMEROUS ACT VALUES OF 999 SECONDS WERE REALIZED OVER A SIGNIFICANT TIME PERIOD DURING WHICH NO HEPARIN WAS ADMINISTERED. UPON REWARMING THE PATIENT, INTO THE 6-HOUR (360MINUTES) MARK OF THE BYPASS RUN, THE PO2 VALUES STEADILY DECREASED AS THEY INTERMITTENTLY WERE MEASURED ON THE POINT OF CARE BLOOD GAS ANALYZER ( ISTAT ). THE DECISION TO CHANGE OUT THE OXYGENATOR WAS MADE UPON PO2 VALUES IN THE 60S (SIXTIES) MMHG RANGE. AN ENTIRE NEW HEART-LUNG MACHINE, WITH A NEW OXYGENATOR AND TUBING PACK WAS UTILIZED TO PERFORM THE CHANGE-OUT. THE CHANGEOUT WAS UNEVENTFUL AND DONE WITHIN A REASONABLE TIME, AND BYPASS WAS RE-INITIATED WITHOUT ISSUES AS PER THE PERFUSIONIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16291808 ↗
• DeathFeb 3, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR INCREASE IN CO2, DECREASE IN O2 (LOWEST PO2 WAS 49). IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE, AND IF THERE WAS ANY BLOOD LOSS. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. AS PER USER FACILITY, THE PATIENT EXPIRED ON THE TABLE, NOT AS A RESULT OF THE OXYGENATOR CHANGE-OUT. ADDITIONALLY, THE CLINICAL SPECIALIST WAS INFORMED BY THE PERFUSIONIST THAT THEY DID NOT COOL THE PATIENT DOWN VERY MUCH COMPARED TO TYPICAL CASES. ACTS WAS UTILIZED FOR THEIR ANTICOAGULATION STATUS, WITH A READING OF 999. THE HEPCON MACHINE WAS NOT USED, AND THEY DID NOT GIVE HEPARIN FOR AN EXTENDED PERIOD OF TIME. THE SHUNT SENSORS WERE ALSO NOT USED DURING THE CASE; THEREFORE, THEY HAD TO SEND BLOOD SAMPLES TO THE LABORATORY OR OBTAIN BLOOD GASES USING POINT OF CARE. WHEN THEY DECIDED TO CHANGE THE OXYGENATOR OUT, THE FAILURE OF THE OXYGENATOR OCCURRED UPON RE-WARMING THE PATIENT AT THE END OF THE CASE. THE PERFUSIONIST WAS ALSO ADAMANT THAT THE DEATH OF THE PATIENT WAS NOT A RESULT OF THE OXYGENATOR FAILURE OR CHANGED OUT. IT WAS COMMUNICATED T

  Patient problems: Cardiac Arrest

  MAUDE report 16291773 ↗
• MalfunctionJan 3, 2023Particulates; Particulates

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A WHITE FLAKE FLOATING IN THE RESERVOIR WAS NOTICED. AS PER THE USER FACILITY, THEY REMOVED THE VENOUS RESERVOIR OUTLET TUBING AND DRAINED THE PARTICULATE PIECE OUT INTO A SPECIMEN CUP. THE OUTLET TUBE WAS REPLACED AND PRIMING WAS FINISHED. THEY WERE ABLE TO RUN THE CIRCUIT WITH NO ISSUES. NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091171 ↗
• MalfunctionNov 10, 2022Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE MANIFOLD MALFUNCTIONED; THE LUER CONNECTION AT THE PROXIMAL END BEFORE THE FIRST STOPCOCK CAME APART. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15774669 ↗
• InjuryApr 26, 2022Gas Output Problem; Leak/Splash; Gas Output Problem; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS THE OXYGENATOR FAILED. PER USER FACILITY THE PATIENT WAS IN FOR A MINI MITRAL VALVE REPLACEMENT WAS IN FOR A MINI MITRAL VALVE REPLACEMENT WHICH WAS SUCCESSFULLY COMPLETED. HE HAD SEVERE AORTIC INSUFFICIENCY AND THE PUMP SUCKERS WERE TURNED TO A HIGH RPM. THE PATIENT WAS COOLED TO 28C NO XCLAMP, AND COLD FIBRILLATORY ARREST OCCURRED. AFTER 1.5 TO 2 HOURS INTO THE CASE, THE ARTERIAL PCO2 STARTED TO RISE ON THE CDI 500, WITH THE SHUNT SENSOR HAVING UNDERGONE A PASSING 2 POINT CALIBRATION BEFORE BYPASS. THE GAS SWEEP WAS RAISED UP AND OVER 10L/MIN WITH THE EPGS ON SYSTEM 1 HLM WITH NO EFFECT TO LOWER THE PCO2, EVEN AFTER REDUCING CO2 FLUSHING TO THE FIELD. A POINT OF CARE BLOOD GAS ANALYZER CONFIRMED PCO2 IN THE 70S. GAS FLOW WAS CONFIRMED EXITING THE SYSTEM 1 HLM BY THE EXTERNAL FLOWMETER AND ALSO HOLDING THE GAS LINE TO THE EAR FOR THE PHYSICAL PRESENCE OF GAS FLOW OUT FROM THE GAS LINE AND GAS FILTER. THE HEPARINIZATION OF THE BLOOD WAS ADEQUATE AND CONFIRMED BY ACTS AND ALSO HEPARIN CONCENTRATION USING HEPCON. THE DECISION WAS MADE TO GO TO A OXYGEN TANK DIRECTLY TO THE OXYGENATOR AT 15-20 L/MIN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoxia

  MAUDE report 14204061 ↗
• MalfunctionMar 25, 2022Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, NOTICED A NICKEL SIZE AIR BUBBLES OVER WHELM THE AF125 FILTER. AS PER SALES, THE PERFUSIONIST WAS CONDUCTING CHECKLIST SOP AND INITIATED A STOP PUMP PROCEDURE TO CONFIRM IT WAS WORKING. AS A RESULT THE RX25RE HAD NICKEL SIZE AIR BUBBLES OVER WHELM THE AF125 FILTER. THE PERFUSIONIST WAS CONCERNED AND REDID THE STOP FUNCTION SAME RESULTS. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905905 ↗
• MalfunctionDec 21, 2021Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY, DURING SETUP, THEY NOTICED A BROKEN CONNECTOR COMING OFF THE OXYGENATOR. NO PATIENT INVOLVEMENT; PRODUCT WAS CHANGED OUT; PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052754 ↗
• MalfunctionDec 3, 2021Precipitate in Device or Device Ingredient; Obstruction of Flow; Precipitate in Device or Device Ingredient; Obstruction of Flow

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THEY WERE UNABLE TO INJECT AND WITHDRAW FLUID FROM THE PORT OF THE RECIRCULATION LINE FRO THE BOTTOM OF THE OXYGENATOR. PER FACILITY, IT APPEARED THERE WAS ALSO DEBRIS IN THE END OF THE LINE NEAREST TO THE PORT. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927358 ↗

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