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

Model Number	CX*FX25RW
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	06/01/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: perfusionist g4: 510k: k1300520.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.The manufacturing record and the shipping inspection record of the actual device - no anomaly was found.Past complaint file - no other similar report of the product with the involved product code/lot number was found.Cause of occurrence/conclusion based on the investigation result, no anomaly was found in the manufacturing records.Since the actual device 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 fx25 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 a small blood leak are detected at the arterial connection port outlet during the setup of the extracorporeal circuit for the patient's surgery.The issue was identified when the circuit was primed.Since the patient was already connected to the cardiopulmonary bypass (cpb) and there was insufficient time to replace the circuit, the leak was resolved by applying a tegaderm to prevent a high-risk situation.The patient experienced hypotension and airway bleeding, which was the cause of death.

• 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: 22343103
• Report Number: 9681834-2025-00117
• Device Sequence Number: 8526888
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)271031(10)241114
• 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): 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): 06/26/2025

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*FX25RW
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 241114
• 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: 06/01/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 50 KG