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

Model Number	CX*FX05RW
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: date of birth: 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 e1: initial reporter name: unknown e1: phone number: unknown g4: 510(k) number: k130280 visual inspection of the actual device upon receipt - no anomaly such as breakage was found.After rinsing and drying the actual device, the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure - it was confirmed to meet the factory's specifications.No anomaly was found.[bovine blood conditions] hb: 12g/dl, temp.: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg [circulation conditions] blood flow rate: 2l/min and 1l/min, v/q:1, fio2: 100% [o2 transfer volume] @2l/min: 122ml/min., @1l/min: 68ml/min [co2 removal volume] @2l/min: 94ml/min., @1l/min: 55ml/min 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# was found.Cause of occurrence/conclusion no other similar report of the product with the involved product code/lot# was found.From the information that "the oxygenator outlet blood gradually became darker", as a possible cause of this case, it was likely that as the patient's metabolism had increased due to rewarming, the oxygen supply was insufficient compared to the oxygen consumption, causing a decrease in svo2.However, since no anomaly was found in the actual device, it was not possible to clarify the cause of occurrence.Relevant ifu reference: - start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.- measure blood gases and make necessary adjustments as follows.A.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.- to decrease pao2, decrease fio2.- to increase pao2, increase fio2.B.Control paco2 by changing the total gas flow.- to decrease paco2, increase total gas flow.- to increase paco2, decrease total gas flow.- upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patients' metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism.- a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 5 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported poor oxygenation during cardiopulmonary bypass (cpd).The oxygenator was changed out.The procedure outcome was not reported.There was no harm to the patient.

• 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: 22696658
• Report Number: 9681834-2025-00137
• Device Sequence Number: 15699840
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: (01)04987350781772(17)270930(10)241002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071572
• 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): 08/03/2025

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*FX05RW
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 241002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 08/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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: Required Intervention
• Patient Age: 24 MO
• Patient Sex: Male
• Patient Weight: 12 KG