MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX FX ADVANCE HOLLOW FIBER OXYGENATOR W INTEGRATED AF W HARDSHELL RES.; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	3CX*FX25RWC
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has received the device for evaluation; however, 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.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, upon rewarming, the partial pressure of oxygen (po2) kept dropping significantly.It was also noticed that red tinged fluid start coming out the primary and secondary exhaust holes.No known consequence or health impact to patient.Product was not changed out.Procedure completed successfully with unknown amount of blood loss.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on january 16, 2026.Upon further investigation of the reported event, the following information is new and/or changed: g3.(date received by manufacturer), g6.(indication that this is a follow-up report), h2.(follow-up due to additional information and device evaluation), h3.(device evaluated by manufacturer), h6.(identification of evaluation codes 10, 3331, 4210, 4307).Visual inspection of the actual device upon receipt found no anomaly such as damage was found.It was observed that the red transparent liquid was dripping on the floor from the image provided.The returned sample has been rinsed and dried, was tested for oxygen transfer and carbon dioxide removal performance, in accordance with the product inspection protocol.The unit met the factory¿s specification, and no anomaly was found.The unit was then leak tested, in which a colored saline solution was filled in the blood channel of the actual device while circulating, no leaks were found.The blood outlet port was blocked and air pressure of 2kgf/cm2 was applied to the blood channel from the blood inlet port.As a result, no leak was observed inside the housing at the gas channel side.Plasma leakage was considered to have occurred from the provided image, and it is possible that the gas could not be exchanged due to a plasma leak.It is possible that the blood properties changed due to some factors, leading to the production of a substance with surface-active properties.This could have disrupted the relationship between the surface tension of the blood and the gas maintained in the micropores of the fiber.As a result, the fiber became hydrophilic, leading to plasma leakage.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX FX ADVANCE HOLLOW FIBER OXYGENATOR W INTEGRATED AF W HARDSHELL RES.
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 24096689
• Report Number: 1124841-2026-00009
• Device Sequence Number: 16006088
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837(17)280731(10)5K04
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 5K04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown