CAPIOX®FX CX*FX15RE30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350701145), received between Mar 25, 2019 and Sep 13, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Deliver” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Failure to Deliver; Infusion or Flow Problem; Failure to Deliver; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE DEVICE PUMP INVOLVED WAS TURNED ON AND CIRCULATION WAS CONDUCTED WITH THE BLOOD FLOW INDEX OF 2.6. WHILE FIO2 WAS 70%, THE FLOW RATE WAS 2L/MIN, AND PAO2 WAS IN THE RANGE OF 260 - 270 MMHG. AFTER 2 HOURS, PAO2 BEGAN TO DROP BELOW 100. THE GAS SIDE WAS CHECKED AND FOUND TO BE FUNCTIONING PROPERLY. THE GAS LINE WAS REPLACED, HOWEVER THERE WAS NO IMPROVEMENT. FLUSHING WAS PERFORMED ASSUMING A WET LUNG, HOWEVER THE SITUATION DID NOT CHANGE. THE GAS FLOW RATE/FIO2 GRADUALLY INCREASED FROM 3/80% > 4/80% > 5/90% > 6/100% > 8/100% > 9/100% > 10/100%, BUT THE PAO2 DROPPED TO 93.3 > 69 > 40.2. NEXT, THE BLOOD FLOW RATE WAS REDUCED TO SEND MORE OXYGENATED BLOOD, BUT THERE WAS NO IMPROVEMENT. THE GAS LINE WAS REPLACED, FLUSHED, THE GAS FLOW RATE INCREASED, AND THE FIO2 WAS INCREASED. THE IDEA OF REPLACING THE OXYGENATOR WAS CONSIDERED, HOWEVER, DUE TO TIME CONSTRAINTS, THE OPERATION WAS FINISHED WITHOUT REPLACEMENT. THE PATIENT IS CURRENTLY IN ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION). THERE IS A RISK OF HYPOXIC ENCEPHALOPATHY, BUT A FINAL DIAGNOSIS CANNOT BE MADE UNTIL THE PATIENT WAKES UP. GIVEN THE PATIENT'S CURRENT ECMO STATUS, IT IS DIFFICULT TO CONFIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211618 ↗
• InjuryMar 25, 2019Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED THAT AFTER A FEW MINUTES FROM THE START IN EXTRACORPOREAL CIRCULATION, THE INVOLVED CAPIOX DEVICE REACHED THE THEORETICAL FLOW SUITABLE FOR THE PATIENT'S BSA. WHEN THEY DETACHED THE MECHANICAL VENTILATION, THE ARTERIAL BLOOD WAS COMPLETELY DARK; NON-OXYGENATED SUPERIMPOSABLE TO VENOUS BLOOD. THEY DECIDED TO RESUME THE MECHANICAL VENTILATION AND TO WEAN THE PATIENT FROM THE CEC FOR THE REPLACEMENT OF THE OXYGENATOR. THE BLOOD FLOW WAS 3.6L/MIN, THE GAS BLENDER FIO2 70% AND THE AIR WAS 1.8L/MIN. THE ACTUAL SAMPLE WAS CHANGED OUT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BLOOD LOSS WAS 300ML. THE PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.

  Patient problems: Blood Loss

  MAUDE report 8448485 ↗