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

Model Number	CX*FX05RW
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: no patient involvement.A2: age or date of birth: no patient involvement.A3a: sex: no patient involvement.A4: weight: no patient involvement.A5: ethnicity: no patient involvement.A6: race: no patient involvement.D6a: implanted date: no patient involvement.D6b: explanted date: no patient involvement.E1: initial reporter name: requested, not provided.E1: phone number: requested, not provided.G4: 510k: k071572, k130280.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The manufacturing and shipping inspection records of the actual device showed no anomalies.A review of past complaint files found no other similar reports for the product with the involved product code and lot number.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 the inlet port of the oxygenator was found to be loose during the device prefilling process.The event occurred before treatment, with no patient involvement.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d4, h3 and provide the completed investigation results.Confirmation of the provided video revealed that the blood inlet port of the oxygenator was wobbly when force was applied with a finger.A visual inspection of the actual device revealed that the blood inlet port had been fractured at the root.In the video showing the device in use, the blood inlet port was not completely fractured, leading to the inference that the fracture occurred during the return process.Upon magnifying inspection of the fractured surface of the actual device, it was observed that the surface was generally smooth.Ripple patterns were found on the bottom side of the oxygenator, with streak patterns extending from them.No foreign substances that could reduce the strength of the device were detected.These observations suggest that an instantaneous force was likely applied to the blood inlet port of the device from the bottom side of the oxygenator, causing the fracture to progress from the center of the ripple patterns towards the direction of the streak patterns.The manufacturing and shipping inspection records of the actual device revealed no anomalies.Additionally, a review of past complaint files showed no other similar reports for the product with the involved product code or lot number.Based on the investigation result, as a possible cause that the blood inlet port was loosened, it was likely that the blood inlet port was about to fracture.As a possible cause that the blood inlet port was fractured, it was inferred that some strong impact load was applied to the bottom side of oxygenator near the blood inlet port.However, from the condition of actual device, it was not possible to identify exactly when the impact load was applied.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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to correct the g3 date from the follow up no.1 supplemental report that was previously submitted.The correct g3 date should have been may 12, 2025.

• Brand Name: CAPIOX FX OXYGENATOR
• 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: 22072598
• Report Number: 9681834-2025-00085
• Device Sequence Number: 8703330
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: (01)04987350781772(17)261130(10)231221
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2025

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*FX05RW
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 240726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 02/20/2026
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/12/2025; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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