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

Model Number	CX*FX05RE
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report was initially submitted on 07feb2025 however the report number was inadvertently submitted as 9681834-2024-00013 instead of the correct number which should have been.Because of that error, the report failed as a duplicate and is being resubmitted with the correct report number.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: perfusionist.G4: pma/510(k): k130280.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.1.The manufacturing record and the shipping inspection record of the actual product: no anomaly was found.2.Past complaint file: no other similar report of the product with the involved product code/lot# was found.3.Manufacturing date: september 25, 2023.4.Cause of occurrence/conclusion: based on the investigation result, no anomaly was found in the manufacturing records.Although the one-way valve for the involved product was installed in the sampling line and purge line, since the actual sample could not be investigated, it was not possible to clarify the cause of occurrence.Relevant ifu reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir." 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
The user facility reported that they had a leaky valve in the fx05.The procedure outcome was not reported.There was no patient injury.

• 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: 21364511
• Report Number: 9681834-2025-00013
• Device Sequence Number: 20936600
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: (01)04987350781758(17)260831(10)230925
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071572
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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 Expiration Date: 08/31/2026
• Device Model Number: CX*FX05RE
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 230925
• 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: 01/10/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• 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