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

Model Number	CX*FX25RW
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: phone number: unknown.G4: 510k number: k130520.The actual device has been returned for evaluation.Visual inspection of the actual device upon receipt.No anomaly such as damage that could lead to failure in the blood flow rate was found.After rinsing and drying the actual device, bovine blood (hct: 35%, temp.: 37°c) was circulated.It was found that a maximum blood flow rate of 7l/min was achieved.After "2", the pressure drop was measured when circulating at each flow rate.It met the factory's specifications, and no obstruction was found.After bovine blood circulation, saline solution was flowed into the blood channel.No blood clot that could lead to the obstruction was formed.The manufacturing record and the shipping inspection record of the actual sample: no anomaly was found.Past complaint file: no other similar report of the product with the involved product code/lot number was found.Manufacturing date: november 26, 2024.Cause of occurrence/conclusion: based on the investigation result, no anomaly that could lead to failure in the blood flow rate was found in the actual device.As a cause of this case, from our past experiences, following factors were inferred.However, since no anomaly was found in the actual device, it was not possible to clarify the cause of occurrence.Due to some factor, the circuit was obstructed, and blood flow rate was not achieved.Since the cannula was in contact with the vessel wall, blood flow rate was not achieved.The tube in the circuit was kinked.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 they had a minimally invasive cardiac surgery (mics) procedure, at the beginning of the cardiopulmonary bypass (cpb), blood flow 1.3l/min, pre-oxygenator pressure 230mmhg, femoral artery cannulae 18 fr., no other problems were found, replaced the oxygenator, everything became normal.The procedure outcome was not reported.The patient was not harmed.Since the oxygenator was exchanged, it was determined to be a serious injury, however, there was no health damage.

• Brand Name: CAPIOX
• 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: 21878788
• Report Number: 9681834-2025-00068
• Device Sequence Number: 12921899
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)271031(10)241126
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: 241126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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: Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 64 KG