MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	CX*FX15RW30
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the reported information.An adult patient with peripheral cannulation and assisted venous drainage had been on pump support for three hours.The medical team was preparing to wean the patient from the pump when the oxygenator began to foam, causing the tubing to pop out.The oxygenator became pressurized, releasing bubbles into the arterial line.The oxygenator was replaced, and retrograde perfusion was performed to remove the bubbles that had entered.The patient's condition was already poor, and he did not survive.There had been a change of operating room, and communication indicated that the wall outlets were malfunctioning.They were pressurizing due to water accumulation or blowing air instead of aspirating.This was believed to have caused the device malfunction.The user assumed that the bleeding issue was related to a problem with the air intakes rather than proper aspiration.The oxygenator was replaced, which added approximately five minutes to the procedure.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: 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.E3: occupation: distributor.G4: 510(k) no.: k130520.The actual device was not available; therefore, the actual device will not be returned for evaluation.No anomaly was found in the manufacturing record and the shipping inspection record.No similar complaint was received regarding the involved product code and lot.Based on the investigation results, no anomaly was found in the manufacturing records.Since the actual device could not be confirmed, it was not possible to clarify the cause of the occurrence.Relevant instructions for use (ifu) reference: the ifu (capiox fx15) of ashitaka factory has the following warnings and caution regarding air mixing: "pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase." "the gas flow rate should not exceed 15l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase." (b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to section a3a.Sex and h1.Male was inadvertently submitted in section a3b., the patient sex could not be obtained.The initial mdr captured "death" in section h1; however, "serious injury" is correct.

• Brand Name: CAPIOX FX15 OXYGENATOR
• 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, 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 23646828
• Report Number: 9681834-2025-00221
• Device Sequence Number: 17349198
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: (01)04987350701169(17)271031(10)241119
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 241119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male