Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RE40Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00699753450158), received between Oct 11, 2018 and Mar 14, 2023 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryNov 9, 2021Clumping in Device or Device Ingredient; Clumping in Device or Device Ingredient

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WERE CLOTS FOUND IN THE OXYGENATOR AND THE BLOOD GASES WERE DROPPING RAPIDLY. THEY WERE ON BY-PASS FOR ABOUT 3 HOURS. THEY WERE ABOUT TO COME OFF BYPASS IN ABOUT 5 MINUTES. THAT IS WHEN BIOGLUE WAS ADMINISTERED TO THE PATIENT. WITHIN ABOUT 5 MINUTES OF BIOGLUE ADMINISTRATION, LITTLE CLOTS WERE NOTICED IN THE OXYGENATOR AND THE BLOOD GASES WERE DROPPING RAPIDLY. THE CUSTOMER FEELS STRONGLY THAT THE BIOGLUE GOT INTO THE CIRCUIT AND CAUSED THE ISSUES. THERE WAS APPROXIMATELY 240 ML OF BLOOD LOSS. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12777974 ↗
• MalfunctionOct 12, 2021Output below Specifications; Output below Specifications

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR PRESENTED A LOW OXYGEN TRANSFER RATE. PER FACILITY, DURING 15 MINUTES OF BYPASS, GASES WITH 64 PO2 - TEMPERATURE 35ºC - FIO2 60% - OXYGEN INCREASED TO 100% IMPACT ON PIO2 340 GASES. 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 12617388 ↗
• MalfunctionAug 20, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A HAIR WAS OBSERVED INSIDE THE RESERVOIR AND ITS EXTERNAL PART. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350137 ↗
• MalfunctionMar 10, 2021Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, EXCESSIVE PCO2 RETENTION OCCURRED WHEN OXYGENATOR WAS CONNECTED. THE PROCEDURE WAS TO CHANGE THE AORTIC VALVE. AFTER 15 MINUTES OF THE AORTIC CLAMPING AND PASSAGE OF THE CARDIOPLEGIA, THE FIRST ARTERIAL GAS SAMPLE WAS TAKEN AND HAD A PCO2 OF 82.2 MMHG. BIOMEDICAL CHECKED THE CENTRAL GASES, AND A BULLET WAS REQUESTED OF OXYGEN TO CONNECT IT DIRECTLY. AT THAT POINT, THE OXYGEN WAS INCREASED FROM 2 TO 5 LITERS. AFTER 5 MINUTES, ANOTHER SAMPLE WAS TAKEN WITH THE RESULT OF PCO2 OF 92 MMHG. THE AIR FLOW WAS INCREASED TO 8.0 LPM AND THE FIO2 100%. ANOTHER SAMPLE OF ARTERIAL GASES WAS TAKEN, WHICH YIELDED A PC02 OF 54.6 MMHG, AT AN AIR FLOW OF 8.0 LPM AND THE FIO2 100% AND THEORETICAL FLOW IC PERFUSION 2.5. THE OXYGEN BULLET WAS DISCARDED AND IT WAS DECIDED TO VENTILATE FROM THE ANESTHESIA MACHINE. ONCE THE ANESTHESIOLOGIST BEGAN TO VENTILATE, A NEW BLOOD GAS SAMPLE WAS TAKEN PRIOR TO THE CEC EXIT. THE PCO2 WAS 33.9 MMHG, WITH WHICH THE GAS FLOW RETURNED TO NORMAL VALUES AND THE CEC EXIT WAS MADE WITHOUT PROBLEMS. NO HEALTH CONSEQUENCES OR IMPACT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456739 ↗
• MalfunctionApr 15, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE SUBSIDIARY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING QUALITY INSPECTION, THEY NOTED EXCESS ITEMS. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9964544 ↗
• MalfunctionJun 28, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE OXYGENATOR WOULD NOT READ THE ARTERIAL TEMPERATURE. NO CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745724 ↗
• MalfunctionJun 21, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THERE WAS NO TEMPERATURE READING ON THE ARTERIAL TEMPERATURE PORT. AS PER THE USER FACILITY, IT WAS RESOLVED BY MANUALLY CALCULATING THE TEMPERATURE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724072 ↗
• MalfunctionJun 21, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SET UP, THERE WAS NO READING ON THE ARTERIAL TEMPERATURE PORT. THE ISSUE WAS RESOLVED BY MANUALLY CALCULATING THE TEMPERATURE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724053 ↗
• MalfunctionOct 11, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR PRESENTED A RETENTION OF CO2 ACCORDING TO THE LABORATORY REPORT. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. NO CONSEQUENCE OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7956271 ↗