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

Catalog Number CX*FX15RW40

Device Problem Leak/Splash (1354)

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

Event Date 10/19/2021

Event Type  malfunction  

Event Description

The user facility reported that the capiox device was used during a heart transplant case.During cpb, act above 750s, hct 20-26.About 5 hrs cpb start, the perfusionist found bubbles with plasma around gas outlet, pco2 increase and po2 decrease.He adjusted fio2 to 100%, po2 could be maintained 92 mmhg until cpb stop.The patient was not harmed.The procedure outcome was not reported.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual sample was received for evaluation.The provided video was inspected.It was found that bubbles were flowed out from the gas outlet side.The actual sample became verminous when it arrived at the factory.Therefore, the leak test of it could not be performed, and it was rinsed immediately after arriving.Visual inspection of the actual sample (after rinsing) did not find any anomaly including a damage.The actual sample was installed into a circuit consisting of tubes, it was filled with water and a pressure test was performed.As a result, it was found that water leaked in a few hours.In the case of a leak due to damage to the product, the leakage occurs immediately after pressurization.Therefore, it was inferred that the fiber of actual sample became hydrophilic due to the blood condition at the time of use, and the leakage occurred through the fiber.To confirm that the origin of leakage was due to the hydrophilization of fiber, bovine blood containing the hydrophilized component was circulated (5 l/min, back pressure 500 mmhg).As a result, only plasma components were found to flow out from the gas outlet side.In the case of leakage due to product damage, whole blood leaks, but in this circulation test, only the plasma component leaked.Therefore, it was likely that the actual sample was not damaged, and that plasma leakage occurred during use.In addition, it was inferred that the gas transfer performance was deteriorated due to the plasma leakage.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: 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 15 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It was likely that the blood properties changed due to some factor, a substance having a surface-active action was produced, and the relationship between the surface tension of blood and gas maintained in the micropores of fiber was broken.This made the fibers hydrophilic, leading to plasma leakage.Due to the increase in the pressure inside the circuit (e.G.During the formation of blood clot), the pressure applied from the blood channel to the gas channel increased.As a result, the force for blood components to flow out to the gas channel increased, leading to plasma leakage.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

• Brand Name: CAPIOX FX 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: mary o'neill ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 12834559
• MDR Text Key: 280942765
• Report Number: 9681834-2021-00199
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701121
• UDI-Public: 04987350701121
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2021

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 Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: CX*FX15RW40
• Device Lot Number: 201127C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 51 KG