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

Model Number	CX*FX25W
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the reported information.Fluid was coming out of the housing.The event occurred after cardiopulmonary bypass.The event did not result in delays with the surgical procedure.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.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.
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.H6: investigation findings - code 4210 is based upon the evaluation of the photo provided; code 213 is based upon functional testing of the returned sample.After reviewing the photo provided, it was found that the fiber appears to be stained light red although it was thought to have been washed with water, etc.Visual inspection of the actual device upon receipt: no anomaly such as damage was found.Leak test of the actual device: colored saline was filled into the blood flow path of the actual device (after washing) and circulated, and no leaks were observed from the housing.After the above, the blood outlet port was blocked and an air pressure of 2 kgf/cm squared was applied to the blood flow path from the blood inlet port.As a result, no leaks were observed from the housing.The manufacturing record and the shipping inspection record of the actual device found no anomaly.No similar complaints have been reported.Based on the investigation results, no anomaly was found in the manufacturing records, and no leaks were found from the housing of the actual device.In this case, based on the condition in the photographs taken after use and that of the actual device, it was thought that the plasma leaking from the gas flow path may have been recognized as a leak from the housing.However, since the circulatory conditions and timing of the leak were unknown, it was not possible to clarify the cause of the plasma leak.Based on our past experience, it is inferred the following are possible causes of the plasma leak, which we would like to report for your reference.The blood properties changed due to some factor, leading to the production of a substance with surface-active properties.This could have disrupted the relationship between the surface tension of the blood and the gas maintained in the micropores of the fiber.As a result, the fiber became hydrophilic, leading to plasma leakage.The instructions for use (ifu) (capiox fx25) indicates as follows regarding leakage: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.".

• Brand Name: CAPIOX®FX
• 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: 23707001
• Report Number: 9681834-2025-00224
• Device Sequence Number: 10629320
• Product Code: DTZ
• UDI-Device Identifier: 04987350701084
• UDI-Public: (01)04987350701084(17)280531(10)250606
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K071494
• 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): 12/03/2025

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: CX*FX25W
• Device Catalogue Number: CX*FX25W
• Device Lot Number: 250606
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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