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

Model Number	CX*FX25RW
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
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: the yellow cap of the three-way valve (blue cock) and the female connector had been damaged.Simulation test: as a result of applying an instantaneous impact load to the yellow cap of a factory-retained sample, the yellow cap and the female connector became damaged in a state similar to that shown in the provided image.The manufacturing record and the shipping inspection record of the actual device no anomaly was found.Past complaint file of the involved produce code and lot number: no other similar report was found.Based on the investigation results, no anomaly was found in the manufacturing records.Since the actual device could not be confirmed, it was not possible to clarify the cause of the occurrence.It was considered possible that some kind of impact load was applied to the yellow cap of the three-way valve based on the provided image, which led to damage.However, it was not possible to clarify exactly when the load was applied.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.
Event or Problem Description
Terumo received the following information: it was reported that when the product was unpacked it was found that the yellow part on the top (sampling system) was broken and fell off.The procedure outcome was not reported.There was no harm to the patient reported.

• 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: 24948694
• Report Number: 9681834-2026-00084
• Device Sequence Number: 20149793
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)280531(10)250618
• 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): 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): 04/21/2026

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: 250618
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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