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

Model Number	CX*FX15RW40
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.G4: pma/510(k): k130520.Visual inspection of the actual sample.It was found that the blood inlet port had been fractured at its base.No anomaly such as a crack or deformation was found around the blood inlet port.Magnifying inspection of the fractured surface of actual sample: regarding the fractured surface, the bottom side of oxygenator was smooth, and a streak pattern were found extending from it.No foreign substance that would reduce strength was found.Due to these factors, it was inferred that instantaneous force was applied to the blood inlet port of actual sample from the bottom side of oxygenator, causing the fracture to progress in the direction of streak patterns starting from the bottom side of oxygenator.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, as a cause of occurrence, it was likely that some strong impact load was applied to the bottom side of oxygenator near the blood inlet port, causing it to fracture.Regarding the timing of impact load, since no anomaly was found in the manufacturing records, it was inferred that the impact load was applied suddenly during distribution or storage.However, from the condition of actual sample, it was not possible to identify exactly when the event occurred in detail.Relevant instructions for use (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.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that when the package was opened, it was found that the oxygenator blood inlet was fractured.The event occurred pre-treatment; therefore, there was no patient involved or harmed.The procedure outcome was not reported.

• Brand Name: CAPIOX®FX
• 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: 21525794
• Report Number: 9681834-2025-00024
• Device Sequence Number: 8339992
• Product Code: DTZ
• UDI-Device Identifier: 04987350701121
• UDI-Public: (01)04987350701121(17)270930(10)241004
• 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): 03/05/2025

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*FX15RW40
• Device Catalogue Number: CX*FX15RW40
• Device Lot Number: 241004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 48 KG