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	10/21/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The user facility reported to terumo cardiovascular that post-surgery and reversal of heparin, patient decompensated and had to go back on cardiopulmonary bypass.Loading dose of heparin was given by anesthesia (35000u heparin) and 20000u heparin was put into the reservoir of the cardiopulmonary bypass circuit.An activated clotting time was run and as it continued to be climbing over 350 seconds bypass was initiated.Fi02 was on 99% with 2.8 lpm of sweep and the blood did not pink up.To rule out any problems with the ventilation module for the quantum bypass machine the oxygen line was switched over to an oxygen tank at 3lpm 100% oxygen.After waiting a couple minutes, it was determined that the oxygenator was not functioning, so they had to terminate cardiopulmonary bypass and cut in a new oxygenator to replace the non-functional one.The surgeon was able to repair the surgical issue, and bypass was not re-initiated.No known consequence or health impact to patient, product was changed out, procedure was completed successfully, there was delay in continuing the surgical procedure.
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 december 11, 2025.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer - 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.
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: 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, with no anomalies such as damage was found.After being rinsed, and dried, the amount of oxygen transfer and carbon dioxide gas removal of the actual sample was measured according to the product inspection protocol.It was confirmed to meet the factory¿s specifications and no anomalies were found.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: 23783996
• Report Number: 1124841-2025-00106
• Device Sequence Number: 14725674
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837(17)280430(10)5F12A
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 03/27/2026

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*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 5F12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 03/02/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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
• Patient Sex: Unknown