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*FX25REC
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
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 oxygenator was not oxygenating.An o2 tank was connected and it still wasn¿t responding.The oxygenator was successfully changed out.Came off cardiopulmonary bypass and the coronary artery bypass grafting procedure was aborted.Patient had saphenous vein graft taken that was not used.As they were off cpb the patient de-compensated and put on extracorporeal membrane oxygenation.There was an unknown amount of delay.The product was changed out.Procedure was completed successfully with 260 ml 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 august 21,2025.Upon further investigation of the reported event, the following information is new and/or changed: a3.A.(added patient's gender).A.4.(added patient's weight).B.5.(updated describe event or problem).B.7.(added other relevant history, including preexisting medical conditions).G.3.(date received by manufacturer).G.6.(indication that this is a follow-up report).H.2 (follow-up due to additional information).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Additional information indicates that the procedure was for a coronary artery bypass graft (cabg).The patient's height is 175 centimeters, with a body surface area (bsa) of 2.1m2.The clinicians also checked the oxygen delivery source, obstructions in source line immediately, along with the biomedical technician and they found it out to be working accordingly.
Event or Problem Description
Additional information from the clinical specialist based on the pump record revealed that, the patient was 175cm tall, weight of 94kg and bsa of 2.1m2.The perfusionist administered 10,000 international units (iu) of heparin into the pump prime.Anesthesiologist gave 30,000 iu heparin at 10:30am to the patient, resulting in an activated clotting time (act) of 348 seconds, below optimal value for bypass initiation.Anesthesiologist then gave an additional 10,000 iu heparin at 10:45am to the patient.The perfusionist went on bypass at 10:49am with an unknown act value.Within minutes, the perfusionist noticed a dark red coloration in the arterial tubing and assumed oxygen failure and notified the surgeon and anesthesiologist.The anesthesiologist immediately started ventilating the lungs.The oxygenator was connected directly to an oxygen tank for gas source.The oxygenation apparently did not improve.The bypass was stopped at 10:54am.The perfusionist gave an additional 20,000 iu heparin into the oxygenator and the patient was placed back on bypass at 10:55am.At 11:15am the act value was 483 seconds, and the partial pressure of oxygen (po2) was 475mmhg with a fraction of inspired oxygen (fio2) of 100 percent and gas sweep of 5 liters/per minute (lpm).
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: b5 (added describe event or problem) 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, 67) the returned sample was visually inspected upon receipt, and was found to have no anomalies, such as damage.After being rinsed and dried, the unit was then tested for the oxygenator transfer and carbon dioxide removal performance, in accordance with the product inspection protocol.As a result, it met the factory's specifications, with no anomalies found.The manufacturing and incoming inspection records were reviewed with no anomalies.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: 22867760
• Report Number: 1124841-2025-00067
• Device Sequence Number: 9338781
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820(17)280331(10)5E14
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: 5E14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 09/26/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 08/28/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 94 KG