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

Model Number	CX*RX05REA
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
Type of Reportable Event	Death
Event or Problem Description
The user facility reported that the involved oxygenator did not function properly.The event occurred during cardiopulmonary bypass.The event resulted in delay in beginning or continuing the surgical procedure.After 3 hours and 40 minutes the device's ability to oxygenate was not functioning.Sweep was at 1.2 lpm and 60% fio2, po2 was 295 then next entry fell to 95 and continued falling despite increases in fio2 and sweep.A second oxygenator was added to the recirculation line to facilitate oxygenation.They did not change out the oxygenator they added another oxygenator to the circuit to finish the case.The surgery was completed successfully.No blood loss was reported.A death occurred.The patient did not die in surgery, they died in intense care unit (icu).
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: perfusion supervisor.The actual sample was not returned.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, no anomaly was found in the manufacturing records.As a cause of decreasing in pao2, based on our past experience, following factors were inferred.However, since the actual sample could not be confirmed, it was not possible to clarify the cause of occurrence.Regarding fio2 during circulation, the amount of oxygen supply was insufficient compared to the patient's oxygen consumption.Gas exchange was hindered by some factor (e.G., blood clot, wet lung).As the patient's metabolism became more active due to rewarming, the oxygen supply was insufficient compared to the patient's oxygen consumption, causing a decrease in svo2.The instructions for use (ifu) (capiox rx05) has the following warnings, method of operation and precaution regarding gas exchange failure: "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.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• 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: 21536636
• Report Number: 9681834-2025-00035
• Device Sequence Number: 7643106
• Product Code: DTZ
• UDI-Device Identifier: 04987350739025
• UDI-Public: (01)04987350739025(17)270228(10)240314
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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*RX05REA
• Device Catalogue Number: CX*RX05REA
• Device Lot Number: 240314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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: Required Intervention; Death; Other
• Patient Sex: Unknown