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

Model Number	CX*FX15RW30
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that there was blood leakage from the oxygenation.During the process of mitral valve mechanical replacement surgery, it was discovered that there was blood leakage from the oxygenator while the cbp had not even.Once the machine was running, the speed of leakage increased.In an emergency situation, the oxygenator bin was replaced.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: date of birth: 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 e1: contact: unknown e1: establishment address: union hospital, tongji medical college, huazhong university of science and technology e1: phone number: unknown e3: occupation: technologist.G4: 510k: k130520.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 of the actual device.No other similar report of the product with the involved product code/lot number was found.Terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
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.Confirmation of the provided video.It was found that a red, transparent liquid had been flowed out of the gas outlet side.Visual inspection of the actual device upon receipt: no anomaly such as damage was found.Leak test of the actual device: the actual device (after rinsing) was installed into a circuit consisting of tubes, and the colored saline solution was circulated.As a result, no leakage was found.The inside of housing on the gas channel side was confirmed when the blood outlet port side was blocked and 2kgf/cm2 air pressure was applied to the blood channel from the blood inlet port side.As a result, no leakage was found.The manufacturing record and the shipping inspection record of the actual device found no anomaly.Past complaint file.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, it was likely that when using the actual device, plasma leakage occurred, and it was found that liquid was leaking from the gas outlet side.As a possible cause of plasma leakage, from our past experience, following factor was inferred.However, since no anomaly leading to the leakage was found on the actual device, it was not possible to clarify the cause of occurrence.The blood properties changed due to some factors, a substance having a surface-active action was produced, and the relationship between the surface tension of blood and gas maintained in the micropores of fiber surface was broken.This caused the fiber to become hydrophilic, leading to plasma leakage.

• Brand Name: CAPIOX®FX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• 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: 22037113
• Report Number: 9681834-2025-00079
• Device Sequence Number: 8415192
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: (01)04987350701169(17)271231(10)250107
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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*FX15RW30
• Device Catalogue Number: CX*FX15RW30
• Device Lot Number: 250107
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/02/2025
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 35 KG