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

Model Number	CX*FX25RW
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the reported information.Foam and bubbles occurred in the reservoir.The event occurred when the vacuum assisted venous drained.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.G4: 510(k) number: k130520.Procedural imaging was provided.The actual device was not returned.Confirmation of the provided image: it was found that there were bubbles in the blood inside the reservoir.Although the fluid level in the reservoir was approximately 1000 ml, it was found that the venous filter was stained red with blood up to approximately 3500 ml.Based on our past experience, when air continues to mix from the venous line, bubbles overflow into the blood.We would like to report this event for your reference.Air mixed in from the venous line accumulates as bubbles in the venous filter.The bubbles that accumulate inside the venous filter were then defoamed with a defoamer.Bubbles that were not defoamed overflowed into the blood.[product structure] - inside the venous filter of the involved product is equipped with defoamer.Air that flows into the venous filter is defoamed by the defoamer.The manufacturing record and the shipping inspection record of the actual device 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 bubbles inside the reservoir, from our past experience, it was likely that air continued to mix from the venous line for some factor, causing bubbles to accumulate inside the venous filter, which then overflowed from the top of venous filter.However, since the actual device was not returned, it was not possible to clarify the cause of occurrence.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-shi, shizuoka 418-0 015; JA 418-0015
• 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 ; 9499890941
• MDR Report Key: 22965074
• Report Number: 9681834-2025-00161
• Device Sequence Number: 9062536
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)280331(10)250422
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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*FX25RW
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 250422
• 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: 08/09/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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