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

Model Number	CX*FX25RW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: contact: requested, unknown.E1: telephone number: requested, unknown.G4: 510(k) no.: k130520.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.Confirmation of the provided image it was observed that red clear liquid was leaking on the floor on the gas-out side of the oxygenator.The manufacturing record and the shipping inspection record of the actual device no anomaly was found.Past complaint file of the involved product code and lot number a similar report of the product with the involved product code/lot# was found at the same facility.Regarding the cause of this occurrence, after reviewing the provided video, the following possibilities were inferred based on our past experience; however, the actual device could not be confirmed and it was not possible to clarify the cause of the plasma leakage.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.Relevant ifu reference: "the 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." 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 following reported information: during the aortic dissection surgery, foamy bloody fluid overflow from gas outlet.No other devices or medications were used in conjunction during the procedure.The plasma leakage was located at the oxygenator site and did not cause harm to the patient.The membrane oxygenator was replaced during the surgery, and the patient is currently recovering well.The procedure outcome was not reported.There was no harm to the patient reported.

• Brand Name: CAPIOX FX25 OXYGENATOR
• 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 ; 9499890941
• MDR Report Key: 23873409
• Report Number: 9681834-2025-00230
• Device Sequence Number: 5330064
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)280630(10)250714
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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 Expiration Date: 06/30/2025
• Device Model Number: CX*FX25RW
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 250714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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 Age: 37 YR
• Patient Sex: Male