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

Model Number N/A

Device Problems Gas Output Problem (1266); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2023

Event Type  Injury  

Event Description

The user facility reported that the involved device oxygenator was used at 19:10, in an emergency case (aortic aneurysmectomy and ascending aorta replacement).The patient was weaned once; however, the pump was restarted at 23:45.Around 01:40, poor oxygenation was evidenced.On the assumption of a wet rung, gas flushing and other measures were taken.It was improved once a little but worsened again.Pao2 is controlled at 200-400 mmhg normally, it reached below 200.No serum leakage occurred.Physician wanted to continue the operation; the oxygenator was changed out around 03:07.The patient had been cooled to about 28 deg.C.They have an impression that oxygenation performance decreases during cooling and rewarming.Large doses of rbc were administered in this case.The event occurred intra-operative.The product was changed out.The patient's final impact was not harmed.

Manufacturer Narrative

Patient identifier: requested, unknown.Age & date of birth: requested, unknown.Patient sex: requested, unknown.Weight: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: clinical engineer.Pma/510(k): k071494, k130520.The actual device has been returned for evaluation.Visual inspection of the actual sample upon receipt found no anomalies in the appearance condition such as a breakage.Air was blown into the gas channel of the actual sample.A slight efflux of foam was observed from gas-out side.The effluent foam was subjected to our protein test paper ("uriace").It was confirmed that the foam contained protein.The actual sample was filled with physiological saline-containing glutaraldehyde solution and fixed, then the housing and filter were removed.Visual and magnifying inspection of the oxygenation module found that the fiber had been discolored in spots.The discolored spots were a partial hydrophilization of the fiber.There was no abnormality in fiber winding condition.The heat exchanger was separated from the outer cylinder and inspected with unaided eye and magnifier.No formation of blood clots was observed.Review of the manufacturing history record and the shipping inspection record of the actual sample confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.The results of the investigation showed partial hydrophilization of fibers leading to plasma leakage.As a cause of the plasma leakage, from our experience, the following factor was inferred.However, it was not possible to clarify the cause of plasma leakage.It was considered probable that some changes in blood properties caused the production of surfactant substances leading to a breakdown of the relationship between the surface tension of blood and gas retained in the micropores on the surface of the fiber, which resulted in a susceptibility to plasma leak.Relevant instructions for use (ifu) reference: 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 20l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.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 FX25 OXYGENATOR
• Type of Device: 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: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16238914
• MDR Text Key: 308066112
• Report Number: 9681834-2022-00276
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2023

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 Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX51804
• Device Lot Number: 220727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2022
• Initial Date FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention