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	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
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.D4: primary unique device identification (udi) number is only the di number.The pi number is not available as the lot number is unknown.
Event or Problem Description
It was reported to terumo cardiovascular that during cardiopulmonary bypass, there was insufficient oxygenation.The procedure was an aortic dissection repair.Two hours after the case was finished and the cannulas were removed, the surgeon detected bleeding in the aortic root.Perfusion was restarted, using the same oxygenator.There was insufficient oxygenation, arterial partial pressure of oxygen 44mmhg (millimeter of mercury) with fraction of inspired oxygen (fio2) at 100%.No thrombus was seen in the oxygenator.An additional fx25 oxygenator was used.No consequence or health impact to patient.Product was changed out.Procedure was completed successfully.
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: d4 (added lot number, expiration date and updated primary unique device (udi) number).D9 (device availability - added date returned to manufacturer).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 - evaluation is in progress, but not yet concluded).H4 (added manufacturing date).A third 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 breakage or similar anomaly was observed on the appearance.After having been rinsed and dried, the sample was tested for the oxygen transfer and carbon dioxide removal performance in accordance with the product inspection protocol.It was confirmed that the actual device met the factory's specifications.The manufacturing record and inspection records of the actual device were reviewed with no anomalies observed.The evaluation of the returned sample was found to meet factory's specifications; therefore, cause of the occurrence could not be determined.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on january 31, 2025.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).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
There was a 3 minutes delay in beginning or continuing the surgical procedure.

• 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: 21284357
• Report Number: 1124841-2025-00006
• Device Sequence Number: 9355256
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820(17)270531(10)4G03
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 05/22/2025

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*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: 4G03
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 01/31/2025; 03/07/2025; 05/01/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/24/2025; 03/28/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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
• Patient Sex: Unknown