Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RW30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00699753450127), received between Aug 17, 2018 and Sep 10, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE OXYGENATOR RESERVOIR GOT CLOT WHILE PRIMING WITH BLOOD. DE-FOAMING CHAMBER AND SCREEN FILTER OF RESERVOIR GOT CLOT RESULTING IN DECREASE OF DYNAMIC VOLUME ( LEVEL) WHILE CIRCULATING AND AIR CAME IN THE CIRCUIT. AS PER THE CLINICAL SPECIALIST, ADDITIONAL INFORMATION FORM THE FACILITY STATES THAT, 1 UNIT OF BLOOD WERE PUT INTO THE RESERVOIR AND A BLOOD FILTER WAS USED IN THE UNITS OF BLOOD WHEN IT WAS PUT INTO THE RESERVOIR. IT IS UNKNOWN AS TO WHAT THE LEVEL OF ANTICOAGULATION WAS OF THE BLOOD INTRODUCED TO THE RESERVOIR AND HOW MUCH HEPARIN WAS PUT IN THE PUMP PRIME. BLOOD IS GOING TO CLOT WHENEVER IS CONTACTS ANY FOREIGN SURFACE IF IT IS NOT ADEQUATELY ANTICOAGULATED. *NO PATIENT INVOLVEMENT *PRODUCT WAS CHANGED OUT PRIOR TO CPB DURING BLOOD PRIMING *PROCEDURE WAS COMPLETED SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452724 ↗
• MalfunctionSep 25, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY, AT THE TIME OF ENTRY IN PARTIAL EXTRA-CORPORARY CIRCULATION, THE PATIENT SATURATION BEGAN TO GO DOWN, REACHING 70%. IT IS UNKNOWN IF THERE IS BLOOD LOSS. AS PER SUBSIDIARY, IT WAS NOTICED THAT THE POST OXYGENER BLOOD SIDE¿S COLORING WAS EQUAL TO THE INSATURED VENOUS RETURN. IMMEDIATELY, AN ARTERIAL GASOMETRY WAS MADE WHERE THE OXYGEN PARTIAL PRESSURE (PO2) WAS 35.2 MMHG, AND THE SATURATION OF OXYGEN WAS 62.1%. IT WAS PROCESSED TO CONNECT AN OXYGEN TANK TO THE OXYGENATOR, THINKING THAT IT COULD BE THE BLENDER OF THE HEART-LUNG MACHINE, AND THE RESULT WAS THE SAME SO THE ANESTHESIOLOGIST WAS REQUESTED TO INCREASE THE FRACTION OF INSPIRED OXYGEN (FIO2) OF THE VENTILATOR TO REMOVE THE PUMP PATIENT, AND CAN REPLACE THE OXYGENATOR TO AN RX25, AND THIS WORKS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10588401 ↗
• MalfunctionNov 11, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT WHITE BITS ON SURFACE OF THE BLOOD WERE OBSERVED. IT IS UNKNOWN WHEN THE EVENT OCCURRED, IF THERE WAS A DELAY IN THE PROCEDURE, IF THE PRODUCT WAS CHANGED OUT, THE RESULTS OF THE PROCEDURE OR IF THERE WAS ANY BLOOD LOSS.

  Patient problems: No Information

  MAUDE report 9306911 ↗
• InjuryNov 12, 2018Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS NO COLOR CHANGE WITH FIO2 AT 65% AND SWEEP AT 2.5 ON A 50KG PT. THE FIO2 WAS INCREASED TO 100% AND SWEEP INCREASED TO 4 TO SEE IF IT WOULD HELP AND OPENED THE PURGE ON TOP OF THE OXYGENATOR TO HELP RECIRCULATE THE BLOOD. THE PO2 AT 100% WAS ONLY 41, ANESTHESIA TURNED ON THE VENT FOR THE O2 TO RISE. THE PO2 ONLY GOT TO 45. AT THAT POINT, IT WAS DECIDED TO CHANGE OUT THE OXYGENATOR. ONCE CHANGED OUT AND DEAIRED, THE PO2 WAS AT 188 WITH JUST 50%. PER USER FACILITY THE PATIENT WAS BEING VENTILATED AS THEY WENT ON BYPASS. THERE WAS A DELAY FOR 10-15 MINUTES. PRODUCT WAS CHANGED OUT. THERE WAS A BLOOD LOSS OF 150 ML. AFTER CHANGE OUT, SURGERY WAS COMPLETED SUCCESSFULLY. POST OP, PATIENT WAS SITTING UP IN BED AND DOING WELL, FOLLOWING COMMENDS,

  Patient problems: Blood Loss; Injury

  MAUDE report 8062603 ↗
• MalfunctionAug 17, 2018Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME, A PO2 OF 330 MMHG WAS NOTED DURING THE PRIMING PROCESS WHEN THE CDI 500 CELL WAS PUT IN-LINE WHICH IS NORMALLY ABOVE 600MMHG. A SAMPLE WAS DRAWN OFF THE PUMP AND IT WAS RUN IT ON THE I-STAT BLOOD GAS ANALYZER. THE 1ST PO2 CAME BACK AT 360MMHG, THE SWEEP GAS WAS TURNED UP TO 3 LITERS PER MIN AND CHECKED FOR CRACKS/LEAKS/LOOSE CONNECTIONS IN THE GAS DELIVERY SYSTEM. THE CDI PO2 VARIED BETWEEN 330-360MMHG. AN OXYGEN TANK WAS THEN BROUGHT TO THE ROOM AND HAD ANESTHESIA RUN A GAS LINE FROM THEIR VENTILATOR THROUGH OUR GAS FILTER AND INTO THE OXYGENATOR. THE VENTILATOR WAS SET AT 100% FIO2 WITH 2 LITERS PER MINUTE OF SWEEP GAS. THE HIGHEST THE CDI READ WAS 365MMHG. ANOTHER I-STAT WAS RAN OFF THE PUMP AND THE RESULTS CAME BACK AT 394 MMHG. THE OXYGENATOR WAS CHANGED OUT. THE PUMP¿S GAS DELIVERY SYSTEM WAS HOOKED TO THE NEW OXYGENATOR AND THE CDI 500 STILL HAD A LOW READING OF 380MMHG. ANOTHER PRIME SAMPLE WAS DRAWN AND CHANGED THE CDI CELL. THE NEW CELL GAVE A READING OF APPROXIMATELY 400MMHG AND THE PRIME GAS FROM THE I-STAT CAME BACK AT 535 MMHG. THE PROCEDURE WAS COMPLETED WITH THE NEW OXYGENATOR WITH NO ISSUES. NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794633 ↗