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

Model Number	CX*RX25RW
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
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.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(6).
Event or Problem Description
The user facility reported poor oxygenation during a cardiopulmonary bypass (cpb) procedure.Po2 50 mmhg, blood flow rate 5l/min, gas flow rate 2.5l/min, fio2 75%.Became normal after the oxygenator was replaced with a new rx25.No patient harm was reported.The procedure outcome was not reported.The event occurred intra-operative.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, and to provide the completed investigation results.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 record of the actual sample.Considering the provided information that the blood flow rate was 5 l/min, gas flow rate was 2.5 l/min, and f io2 was 75 %, the following possibilities were inferred as the cause of this incident, but we were unable to confirm the actual product and could not determine the cause.The gas flow rate was low compared to the blood flow rate.Since fio2 was not 100%, oxygen supply quantity was insufficient.Relevant instructions for use (ifu) reference: "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 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.(page10 warinig).".
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide a correction to sections d1: brand name, d4: model number, d4: catalog number, and d4: udi.The udi was updated to match the correct format.Due to internal review, a correction was made to section d3.

• Brand Name: CAPIOX®RX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya 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 ; 4103927218
• MDR Report Key: 18363458
• Report Number: 9681834-2023-00260
• Device Sequence Number: 12765962
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: (01)04987350769572(17)250731(10)220810
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/31/2025
• Device Model Number: CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: 220810
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 08/08/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 12/27/2023; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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
• Patient Sex: Male
• Patient Weight: 92 KG