Capiox FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.
Received Jul 28, 2026 · Event occurred Jun 29, 2026
Report 1124841-2026-00075 · MDR key 50061272
Device
Generic name
Oxygenator, Cardiopulmonary Bypass
Manufacturer
Terumo Cardiovascular Systems CorporationModel number
3CX*FX15RE40CCatalog number
N/A
Lot number
6C02
Product problems
- Use of Device Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The user facility reported to Terumo Cardiovascular that during cardiopulmonary bypass, there was an oxygenator failure. First pO2(Partial Pressure of oxygen) at 100% FiO2 (Fraction of inspired oxygen), 3 LPM (liters per minute), sweep was 390, subsequently dropping to 244 and then 130 and then in line readings as low as 70. Cross tested with oxygen tank to double verify. An FX25 was cut in to supplement mid case. *No Health Consequences or Impact.*Procedure completed successfully with 25-50cc of blood loss.
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. For this reason, Terumo references evaluation conclusion code 11.