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	07/02/2025
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, the partial pressure of oxygen (po2) started dropping in the range of 100-150.The event involved a young big built 36-year-old patient, (190cm and 110kg) for an emergency aortic dissection, wherein flows of around 5.7 liters per minute (l/pm) and cooled to 20 degrees.Just after the rewarming to 37 degrees; an aortic cross clamp was released, and the partial pressure of oxygen (po2) started dropping while waiting for reperfusion, ranging from 100-150.The arterial blood gas (abg) showed 130 seconds.As time went by, it was staggering around 100-120 for full flows of 5.7 l/pm.The fraction of inspired oxygen was 100% since start of rewarming.The product was not changed out, as ventilation recommenced and continuous clinical observation.*no health consequences or impact to patient *product was not changed out *procedure completed successfully.
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 july 29, 2025.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, 213, 4315).The retuned sample was visually inspected upon receipt with no anomaly such as breakage was noted.The unit was then rinsed and dried, and the amount of oxygen transfer and carbon dioxide gas removal were measure according to the product inspection procedure.The tests were confirmed to meet the factory's specification, with no anomalies found.The manufacturing and incoming inspection records were reviewed, and no anomalies were found.The evaluation of the returned sample was found to meet the factory's specifications; therefore, the root cause could not be identified.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: 22650353
• Report Number: 1124841-2025-00059
• Device Sequence Number: 12961351
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837(17)270531(10)4G10A
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: 4G10A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2025
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIVANOVA S5HEARTLUNGMACHINELIVANOVA TUBINGPACK
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 110 KG