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

Model Number	CX*FX15RW30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the water outlet port was broken.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.E1: contact name: requested, not provided.E1: phone number: unknown.The actual device has been returned for evaluation.Visual inspection of the actual device: - it was found that the distal end of water outlet port had been deformed.- no anomaly such as damage was found in other sections.Magnifying inspection of the actual device: - it was found that the water outlet port had been deformed from the outside to the inside, as if it had been crushed.Simulation test: - a load was applied to the distal end of water outlet port of the current product, as if pressing against a hard surface.It was found that the distal end of port was deformed.- an impact load was applied to the distal end of water outlet port of the current product.It was found that the distal end of port was similarly deformed.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: november 19, 2024.Cause of occurrence/conclusion: based on the investigation result, from the simulation test result, it was likely that the distal end of water inlet port was deformed due to some load 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: 21878786
• Report Number: 9681834-2025-00061
• Device Sequence Number: 15613465
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: (01)04987350701169(17)271031(10)241119
• 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: 241119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• 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: 11/19/2024
• 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 Sex: Unknown