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

Model Number	CX*FX15RW30
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the sampling tube was disconnected from the blood outlet port.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device has been returned for evaluation.Visual inspection of the actual device: - it was found that the sampling port connected to the blood outlet port had been damaged at the base.- it was also found that the blood cardioplegia port and gas outlet port had been deformed.Magnifying inspection of the actual device: - it was found that the damaged surface on the blood outlet port side had been deformed starting from between the front and bottom surfaces of the oxygenator.- regarding the sampling port side, it was found that the port was deformed and the internal tube was also crushed.Due to these factors, it was inferred that the sampling port was deformed due to the strong force applied to it, exceeding its limit strength and was damaged.Simulation test: - a strong impact load was applied to the sampling port of current product.As a result, it was found to be damaged at the base.- magnifying inspection was performed on the damaged surface on the damaged blood outlet port side.As a result, it was found that it was deformed starting from between the front and bottom surfaces of the oxygenator, as in the actual device.- regarding the sampling port side, it was also found that the port was deformed and the internal tube was also crushed.The manufacturing record and the shipping inspection record of the actual sample - no anomaly was found.Past complaint file: - no other similar report of the product with the involved product code/lot number was found.Manufacturing date: may 27, 2024.Cause of occurrence/conclusion: based on the investigation result, from the simulation test result, it was likely that the sampling port was damaged due to some strong force being applied suddenly.However, based on the condition of actual sample, it was not possible to clarify exactly when this event occurred.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
• 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: 21878787
• Report Number: 9681834-2025-00062
• Device Sequence Number: 8641267
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: (01)04987350701169(17)270430(10)240527
• 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): 04/21/2025

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: 240527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• 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: 11 YR
• Patient Sex: Male
• Patient Weight: 35 KG