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	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the reported information.The venting tube broke at its junction with the reservoir.The procedure outcome was not reported.The event occurred pre-treatment; therefore, no patient was involved or harmed.
Additional Manufacturer Narrative
G4: 510(k) no.: k130520.H6: investigation findings - code 3211 is based upon the evaluation of user facility information and the investigation of the photo provided; code 3221 is based upon no sample returned.The actual sample was not returned for evaluation; however, a photo was provided.Confirmation of the provided image: the l-shaped connector was found to be damaged.Simulation test: as a result of applying an instantaneous tensile load from the top of the reservoir to a factory-retained l-shaped connector, it was recognized that the l-shaped connector was in a different damaged condition from the provided image since the fitting part of it was bent and not broken.As a result of applying excessive clamping to a factory-retained l-shaped connector with a forceps, it was recognized that the l-shaped connector was in a different damaged condition from the provided image since it had a trace of a forceps, the broken surface became narrower, and the cavity was distorted.As a result of applying an impact load to a factory-retained l-shaped connector from the upper side of it, it was recognized that the l-shaped connector was in broken condition, which was similar to the condition in the provided image.The manufacturing record and the shipping inspection record of the actual device found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation results, no anomaly was found in the manufacturing records.The actual device could not be confirmed, and it was not possible to clarify the cause of the occurrence.It is considered possible that some kind of impact load was applied to the l-shaped connector, which led to damage based on the damage condition in the provided image.However, it was not possible to clarify exactly when the load was applied.Relevant instructions for use (ifu) reference: "the ifu (capiox fx25) indicates as follows, 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: 24178020
• Report Number: 9681834-2026-00001
• Device Sequence Number: 9524652
• 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): 01/26/2026

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: 01/04/2026
• Initial Report FDA Received Date: 01/26/2026
• 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