MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	1CX*FX05REA
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: chief of perfusion.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past complaint file.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
Terumo medical corporation received the reported information.There was excess water from the gas line connection to trap.The event occurred during prime.The event did not result in the delay of the surgical procedure.The product was changed out, and the surgery was completed successfully.The event did not cause or contribute to an injury.No blood loss was reported.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Visual inspection of the actual device upon receipt: no anomaly such as damage was found.A red mark was found on the gas outlet port of the oxygenator.Leak test of the actual device: the actual device was incorporated into a tube circuit and colored saline solution was circulated, resulting in no leaks.The blood outlet port of the actual device was clamped, and a pressure of 2kgf/cm² was applied to the blood channel from the blood inlet port.As a result, no leaks were observed.The manufacturing record and the shipping inspection record of the actual device found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, no leak was found in the actual device.As a possible cause of occurrence, the following factors were inferred.However, since no leak was found in the actual device returned and it was not possible to simulate the issue noted in the complaint, the cause of occurrence could not be clarified.A leak was from the connection between the oxygenator inlet port and the tube.Water drops dripped due to condensation on the gas outlet side.The instructions for use (ifu) (capiox fx05) has the following warning and method of operation regarding leakage: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir.".

• Brand Name: CAPIOX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24004169
• Report Number: 9681834-2025-00254
• Device Sequence Number: 13389218
• Product Code: DTZ
• UDI-Device Identifier: 04987350739063
• UDI-Public: (01)04987350739063(17)280331(10)250416
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K071572
• 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
• Report Date (Section B): 01/08/2025

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: 1CX*FX05REA
• Device Catalogue Number: 1CX*FX05REA
• Device Lot Number: 250416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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