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

Model Number	CX*FX25E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3a: sex: requested, not provided a4: weight: 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: phone number: unknown e3: occupation: chief of perfusion the actual device was not available; therefore, the actual device will not be returned for evaluation.Confirmation of the provided image: it was found that the blood inlet port of the oxygenator was deformed from the outside toward the inside.The manufacturing record and the shipping inspection record of the actual device found no anomaly.No similar complaint was received.Based on the investigation results, no anomaly was found in the manufacturing records.It was inferred that some kind of external load was applied to the blood inlet port, leading to the deformation from the provided image.However, since the actual device could not be confirmed, it was not possible to clarify the cause of the occurrence.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: the blood inlet was warped on the oxygenator.The event occurred during setup, and the event resulted in a few minutes delay to change the product out, less than five minutes.The product was changed out, and the surgery was completed successfully.There was no patient injury or blood loss.

• Brand Name: CAPIOX®FX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 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: 24591771
• Report Number: 9681834-2026-00050
• Device Sequence Number: 8828624
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: (01)04987350701060(17)280331(10)250403
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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*FX25E
• Device Catalogue Number: N/A
• Device Lot Number: 250403
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/13/2026
• 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