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

Model Number	N/A
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved capiox device had poor oxygenation after three (3) hours cardiopulmonary bypass (cpb).At that time aortic unclamped and heartbeat was recovered.The oxygenator was replaced with a new rx25.Total cpb time was about 350 mins.The patient final impact was not harmed.The patient was not injured, medical or surgical intervention was not required.The event occurred intra-operative.
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Date of birth: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Phone number: requested, unknown.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and shipping inspection record of the actual sample had no anomalies was found.Review of the past complaint file of the involved product code/lot revealed no other similar reports found.According to the investigation result, no anomalies were found in the manufacturing records.As a cause of occurrence in this case, from the description of the event that the poor oxygenation occurred at that time of unclamping, it was inferred that blood with low so2 might have flowed in the oxygenator.However, since the inspection of the actual sample was not possible, in addition, circulation condition and other information were unavailable, it was not possible to clarify the cause.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.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.(warning) terumo medical products (tmp) (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 RX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• 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: 17039197
• Report Number: 9681834-2023-00086
• Device Sequence Number: 6898185
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040210
• 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): 06/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 221005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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 Age: 39 YR
• Patient Sex: Male