MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: phone number: requested, unknown.E2: health professional: requested, unknown.E3: occupation: requested, unknown.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, no anomaly was found.Past complaint file, no other similar report of the product with the involved product code/lot # was found.Terumo medical products (tmp) (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 the involved pao2 went from 300 to 100.The event occurred during a cardiopulmonary bypass.There was no delay in the procedure surgery and was completed successfully with no patient harm.The blood loss was less than 100 ccs.
Additional Manufacturer Narrative
The actual device has been returned for evaluation.Visual inspection of the actual sample upon receipt, no anomaly such as a 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.Bovine blood conditions hb: 12g/dl, tempertaure: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg circulation conditions - blood flow rate: 6l/minute and 4l/minute, v/q:1, fio2: 100% o2 transfer volume at 6l/minute: 369ml/minute, at 4l/minute: 272ml/minute co2 removal volume at 6l/minute: 292ml/minute, at 4l/minute: 215ml/minute no pump record was available.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 # was found.Based on the investigation result, the gas transfer performance of actual sample after rinsing met the factory's specifications, and no anomaly was found.Since no anomaly was found in the actual sample, the cause of occurrence could not be clarified.The instructions for use (ifu) (capiox fx25) has the following warnings and precaution regarding gas transfer 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 increasing in patient's 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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to correct section d3.

• Brand Name: CAPIOX FX25
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, MD 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17761135
• Report Number: 9681834-2023-00189
• Device Sequence Number: 15119431
• Product Code: DTZ
• UDI-Device Identifier: 04987350701084
• UDI-Public: 04987350701084
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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
• Device Expiration Date: 12/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 1CX*FX25W
• Device Lot Number: 221228
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 12/15/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/20/2023; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• 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