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	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, had bubble detector go off stopping bypass run that required manipulations to get air out of circuit.As per user facility, after removal, cardiopulmonary bypass (cpb) was continued for 5 more minutes before another air alarm.Cpb was temporarily terminated again, and air was seen on top of the oxygenator.When perfusionist opened purge line, the air went down instead of up.The patient arterial line was clamped at the field and again air required removal by surgeon at the point of luer-lock on the cannula.After the air was removed cpb was reinstituted without incident for the remainder of the procedure.Delay was 5 minutes during the bypass run in which the patient had no perfusion.No health consequences or impact.Product was not changed out.There was a minimal amount of blood loss while de-airing the arterial line.Procedure completed successfully with 5 minutes delay.
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 13, 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).H3 (evaluation is in progress, but not yet concluded).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: b1 (added report type).B2 (added outcome attributed to adverse event).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 unit was visually inspected and was found to have no anomaly that could lead to air mixing.The unit was then rinsed, and bovine blood was circulated through the unit at a blood flow rate of 0 to 7l/minute.No anomaly such as leakage or mixing was found.The performance of removing bubbles of the returned unit was tested under the following conditions, where 30ml of air was flowed form the blood inlet port side of oxygenator while bovine blood was circulating.No air was flowed out of the oxygenator through the filter.Additionally, an arterial filter was connected to the blood outlet port side, and it was confirmed whether air was flowing into the oxygenator and arterial filter.After intentionally flowing air into the oxygenator from the blood outlet side, the purge line was opened, and the pump was rotated.It was found that the air was removed into the purge line.The evaluation of the actual device was found to have no anomalies that could lead to leakage or air mixing, and no anomalies in the air bubble removal performance test; therefore, a root cause could not be determined.A review of the device history records revealed no manufacturing issues related to the reported event.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: 22205929
• Report Number: 1124841-2025-00049
• Device Sequence Number: 15364729
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837(17)271231(10)5A06
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/11/2025

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*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 5A06
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 08/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/02/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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