CAPIOX®RX CX*RX15RE40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04987350771070), received between Sep 21, 2016 and Jul 22, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. AT 9 AM, AFTER PUTTING THE CANNULA AND STARTED BYPASS WITH HLM FOR PATIENT, AFTER THREE MINUTES, THE DOCTOR FOUND THAT THE BLOOD IN OUTLET (ARTERIA) HAD A DARK COLOR ALTHOUGH PARAMETERS OF GAS FLOW: 4 L/MIN, FIO2: 100%. HE SUSPECTED THAT ABILITY OF OXYGEN EXCHANGE WAS VERY LOW AND START TO BLOOD GAS; FOUND THAT PO2: 54,7 MMMHG (NORMAL 300 MMHG). HE CHANGED THE AIR MIXER; HOWEVER, THE INCIDENCE WAS NOT IMPROVED. HE STOPPED BYPASS AND CHANGED FOR A NEW OXYGENATOR (CX*RX25RE WITH LOT: 181207K) AND STARTED BYPASS AGAIN AND FOUND THAT BLOOD IN OUTLET WAS FRESH RED AS THE EXPECTATION AND CHECKED BLOOD GAS OF PATIENT WITH PO2: 558 MMHG. THE PROCEDURE OUTCOME AND PATIENT CONDITION WAS NOT REPORTED.

  Patient problems: No Information

  MAUDE report 10307019 ↗
• MalfunctionAug 8, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE USER FACILITY REPORTED THAT DURING THE PRIMING PROCEDURE, THE PERFUSIONIST NOTICED AN AIR BUBBLE IN THE CAPIOX DEVICE OXY WITHOUT A SIGNIFICANT REASON. SHE LOOKED FOR MANY SOURCES TRYING TO IDENTIFY THE LOCATION WHERE AIR BUBBLES ARE ENTERING TO OXY, BUT SHE DID NOT SEE NOTHING RELATED WITH RECIRCULATION LINES OR STOCK AWAY OPEN. BEFORE THINKING OF TO CHANGE THE DISPOSABLE, SHE RECIRCULATED CIRCUIT USING HIGH FLOW 5 L/ MIN FOR 1 MINUTE, THEN SHE STOPPED THE PUMP AND AGAIN NOTICED AIR ENTER THE OXY. FOR THIS REASON, SHE CHANGED THE DISPOSABLE AND USE ANOTHER TERUMO PRODUCT OF THE SAME CODE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874059 ↗
• MalfunctionFeb 6, 2018Break; Break

  THE USER FACILITY REPORTED WHEN THE DEVICE WAS TAKEN OUT OF THE BOX, THEY FOUND THAT THE OXYGENATOR WAS INSIDE THE BAG, HOWEVER, THE RESERVOIR WAS NOT ATTACHED TO THE OXY. IN ADDITION, A CAP ON THE SAME RESERVOIR UNIT BROKE THE STERILE PACK. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7245162 ↗
• MalfunctionSep 21, 2016Connection Problem; Connection Problem

  THE USER FACILITY REPORTED CLOGGING DURING THE USE OF A CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PERFUSIONIST RECEIVED A BOX WITH AN OXYGENATOR FOR NEW PROCEDURE; IT WAS REPORTED HE UNPACKED THE BOX AND HE OBSERVED THAT THE MANIFOLD WAS BROKEN IN PIECES; IT WAS REPORTED THAT HE TRIED TO REPAIR IT BUT WAS UNSUCCESSFUL, SO HE NEEDED TO UTILIZE ANOTHER KIND OF DEVICE IN ORDER TO CONDUCT THE BCP; IT WAS REPORTED THAT HE DISCARDED THE TERUMO SET AND CHANGED IT OUT FOR OTHER; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5966474 ↗