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*FX15RW30C
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
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 13, 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 returned sample was visually inspected upon receipt with no anomaly such as damage that could lead to air contamination.Bovine blood was circulated through the returned device, at a blood flow rate of 0 to 4 l/min.No leakage or air contamination was observed.The bubble removal performance was also checked while bovine blood was circulated, 30 ml of air flowed into the device from the blood inlet port side.As a result, no air bubble was confirmed flowing out from the oxygenator through the filter.Additionally, an arterial filter was connected to the blood outlet port side to check if air flows out to the oxygenator and the artarial filter.A review of the device history records revealed no manufacturing issues related to the reported event.Upon evaluation of the returned sample, it was found to have no anomalies that could lead to leakage or air contamination, and the unit passed the bubble removal performance test.Therefore, a root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator had air bubbles which stopped the pump.As per the subsidiary, the oxygenator was being used for straightforward coronary artery bypass grafting.Priming was uneventful with plasma-lyte and 20% albumen; "small tubing circuit" used as patient body surface area < 1.8.Priming gas confirmed partial pressure of oxygen (po2) > 550.The activated clotting time (act) 776 sec after heparin.Arterial line placed by surgeon, line pressures checked, and equal to mean arterial pressure (map).Right atrial pressure (rap) performed.The venous line was placed by a surgeon."on bypass" with vap performed.Sevoflurane started.Some low flows - venous occluder fully opened.Cardioplegia line primed.Flows down for cross-clamp placement.Anterograde aortic root hyperkalemia blood cardioplegia run, good pressure response.3 minutes into plegia, "arterial air alarm" and pump stopped.Perfusionist inspected arterial line - air visible just distal to bubble device.Arterial line clamped on patient side of air.Recirculation line opened, arterial line briefly opened to allow back flow.Arterial line reclamped and recirculation run from oxygenator to confirm no further air.Purge line from oxygenator opened.Arterial line reopened and flows re-established.90 seconds to complete with no flow.1 minute later further arterial air alarm - this time no air visible in line but appeared device not fully closed.Device clamped, alert override.Flows re-established and remainder of case was uneventful.No health consequence or impact product was not changed out procedure completed successfully with a 90 second delay.
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.

• 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: 22206161
• Report Number: 1124841-2025-00050
• Device Sequence Number: 12673524
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783(17)271231(10)5A13
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151389
• 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): 08/04/2025

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*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: 5A13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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
• Patient Sex: Unknown