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

Model Number	CX*FX25RW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: no patient involvement.A2: age & date of birth: no patient involvement.A3: patient sex: no patient involvement.A4: weight: no patient involvement.A5: ethnicity: no patient involvement.A6: race: no patient involvement.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: distributor.G4: 510(k) no.: 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.History investigation of the product with the involved product code/lot number - 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 following reported information: blood sampling three way broken and blocked.The procedure outcome was not reported.There was no harm to the patient reported.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Appearance confirmation of the actual device upon receipt - the yellow cap on the three-way valve (red valve) had been damaged.- a part of the damaged cap had been fitted to the port.Appearance confirmation of the actual device with a microscope (after cleaning) - no foreign matter or air contamination that could lead to a loss of strength was observed on the damaged surface of the yellow cap.Simulation test - as a result of applying a sudden impact load to a factory-retained yellow cap, it was observed that it broke with a part of the cap fitted into the port.- upon inspecting the appearance of the damaged surface of the broken yellow cap with a microscope, it was confirmed that the damage was similar to that of the actual device.The manufacturing record and the shipping inspection record of the actual device - no anomaly was found.Past complaint file - no other similar report of the product with the involved product code/lot# was found.[cause of occurrence/conclusion] based on the investigation results, it was considered possible that the yellow cap of the three-way valve broke due to some impact load; however, it was not possible to clarify when the load was applied from the condition of the actual device.Relevant ifu reference: - do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.- if the product is dropped during set-up, do not use it.Replace with another device.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX®FX
• 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: 24480175
• Report Number: 9681834-2026-00033
• Device Sequence Number: 10221460
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)280731(10)250826
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/01/2026

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*FX25RW
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 250826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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