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

Model Number	CX*RX25RW
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.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.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).
Event or Problem Description
The user facility reported low oxygenation with the involved capiox.The incident occurred during patient on bypass (cardiovascular).The dark blood in circulation noticeable after cross clamp.The oxygenator exchange was conducted after aortic cross clamp off/unclamped.The new oxygenator working well until end of the case.The patient was reported stable and with no harm.The involved product was replaced.The procedure outcome was not reported.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The device was returned to ashitaka factory (manufacturer).Visual inspection of the actual sample upon receipt.No anomaly such as breakage was found.After rinsing and drying the actual sample, 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: 6l/min and 4l/min, v/q:1, fio2: 100%.[o2 transfer volume] @6l/min: 387ml/min., @4l/min: 279ml/min.[co2 removal volume] @6l/min: 298ml/min., @4l/min: 222ml/min.Confirmation of the condition of actual sample during gas exchange performance.The color of venous and arterial blood was confirmed.It was found that the color of arterial blood was bright red compared to the color of venous blood.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.Past complaint file.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, the gas exchange performance of actual sample after rinsing met the factory's specifications, and no anomaly was found in the manufacturing records.Since no anomaly was found in the actual sample after rinsing, it was not possible to clarify the cause of occurrence.Relevant instructions for use (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 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.".

• Brand Name: CAPIOX®RX
• 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: 21525793
• Report Number: 9681834-2025-00034
• Device Sequence Number: 8339991
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: (01)04987350769572(17)270831(10)240905
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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*RX25RW
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 240905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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 Sex: Unknown