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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the polyester filter in the venous reservoir didn¿t allow the transit of blood coming from suckers and vent.As per the subsidiary, after usage for 296 minutes of capiox fx25 advance oxygenator in cardiopulmonary bypass during an intervention of aortic dissection type a, replacement of the device became necessary because the polyester filter in the venous reservoir didn¿t allow the transit of blood coming from suckers and vent and it was not possible to give any kind of fluid to the patient through the ports on the reservoir.All these problems made impossible go on with bypass.In accordance with cardiac anesthetist, the replacement of oxygenator has been made; the patient was weaned from cardiopulmonary bypass with a duration of change for 3 minutes and then was started again to end the surgery.Product was changed out.There was a 3 minute more or less delay in the beginning of the surgical procedure was completed successfully.
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.
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 june 26, 2025.Upon further investigation of the reported event, the following information is new and/or changed: 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 and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 3331, 213, 67).The returned sample was inspected upon receipt with no anomalies were noted.The sample was tested for the cardiotomy filter break through time, break through volume, and static volume.All results were within specifications.The evaluation of the returned sample was found to function as intended and a definitive root cause could not be determined.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: 22342378
• Report Number: 1124841-2025-00053
• Device Sequence Number: 18398310
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820(17)271231(10)5A27
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: Other
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: 5A27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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