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

Model Number	CX*FX15RW30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e1: contact: requested, unknown e1: telephone number: requested, unknown e2: health professional: requested, unknown e3: occupation: requested, unknown g4: pma/510(k): k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.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 number was found.3.Manufacturing date: august 1, 2024.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 during priming the perfusionist found leakage from the bottom of reservoir.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Confirmation of the provided image it was found that there was a crack on the outlet side of reservoir, which was causing the leak.Visual inspection of the actual sample it was found that there was a crack on the side of the outlet of reservoir, running down to the bottom.Leak test of the actual sample saline solution was poured into the actual sample.As a result, it was found to be leaked from the crack.Confirmation of the actual sample with birefringent lens no difference was found in the resin filling state (rainbow pattern) compared to the current product.Simulation test a strong impact load was applied to the side of reservoir.As a result, it was found that there was a crack on its side, running down to the bottom.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# was found.Manufacturing date: august 1, 2024.Cause of occurrence/conclusion based on the investigation result, as a cause of occurrence, it was likely that a strong impact load was applied to the actual sample, causing it to crack.However, based on the condition of actual sample, it was not possible to clarify exactly when the impact load was applied.Relevant ifu reference: do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx15 oxygenator and reservoir.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).

• 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: 21356804
• Report Number: 9681834-2025-00015
• Device Sequence Number: 20792450
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: (01)04987350701169(17)270731(10)240801
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: 240801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: 68 YR
• Patient Sex: Male