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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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." 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
Terumo medical corporation received the reported information.The patient had central cannulation.The surgery proceeded normally; however, after 75 minutes with the pump, blood foam appeared inside the oxygenator.Due to the pressure, the quick-filling tubbing popped out quickly, resulting in blood loss.Assisted venous drainage was not required.The oxygenator was replaced, which added approximately five minutes to the procedure.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide corrections to sections b3 and g3.31-oct-2025 was inadvertently input in section b3 on the initial mdr; however, 30-oct-2025 is the correct date.30-oct-2025 was inadvertently input in section g3 on the initial mdr; however, 31-oct-2025 is the correct date.

• 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: 23646830
• Report Number: 9681834-2025-00222
• Device Sequence Number: 4823260
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: (01)04987350701169(17)270930(10)241010
• 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?: 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: 241010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• 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: 10/10/2024
• 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: 11 YR
• Patient Sex: Unknown