MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	CX*FX25RE
Medical Device Problem Codes	Leak/Splash (1354); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: sales.G4: 510(k) no.: k130520.The actual sample was discarded by the involved facility.Confirmation of the provided video and image: it was observed foam flowed out of the gas port of the oxygenator, and a clear red liquid was dripping from it.The manufacturing record and the shipping inspection record of the actual device found no anomaly.No other similar report was found.Based on the investigation results, no anomaly was found in the manufacturing records.The actual device could not be confirmed, and it was not possible to clarify the cause of the occurrence.However, based on the video showing foam flowing out, the following possibilities can be considered.It was thought possible that the blood properties changed due to some factor, leading to the production of a substance having surface-active properties.This could have disrupted the relationship between the surface tension of blood and gas that had been maintained in the micropores of the fiber.As a consequence, the fibers became hydrophilic, leading to the plasma leak.Relevant instructions for use (ifu) reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir." 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 received the following reported information: there was air in the filter.The event occurred during bypass, the patient was involved.The end of the procedure (4 hrs 12 min), third party tubing pack.The procedure was not delayed, and the device was not replaced.There was no impact on patient, patient treated as intended.

• Brand Name: CAPIOX FX25
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya-shi, shizuoka 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 25102146
• Report Number: 9681834-2026-00092
• Device Sequence Number: 5031351
• Product Code: DTZ
• UDI-Device Identifier: 04987350701022
• UDI-Public: (01)04987350701022(17)280331(10)250403
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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*FX25RE
• Device Catalogue Number: CX*FX25RE
• Device Lot Number: 250403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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