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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

The user facility reported that the capiox device involved was used for a heart transplant case.After priming, the oxygenator worked well, and no leakage was found.After 120 minutes of by-pass, tiny red blood spots were found on the connecting junction (water inlet and outlet side) part of the oxygenator.Blood leaked from the blood route to the air route.More red spots (blood) were found, and leaking seemed to become worse.The device was replaced with a new fx with the sampled lot number immediately.The second fx worked as normal for the first 100 minutes; however, leakage was found after that.Air bubbles were noticed between the "junction" part side of the oxygenator.The case was almost finished after the leakage was notices, the oxygenator was not changed out.The leakage did not cause any harm to the patient.The patient was in stable condition after the surgery.The patient parameter was normal during the surgery, fraction of inspired oxygen (fio2) , po2 , pco2 normal, hct 28-29.Liver and renal function were normal.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: distributor.Pma/510(k): k130520.(b)(4).Visual inspection of the actual sample upon receipt did not find any damage or other anomalies in the appearance.In addition, it was found that the cross section of fiber of both gas-in and gas-out side had been discolored red.The provided video showed that foamy liquid was flowing out from gas-out side.After the actual samples were rinsed, the blood channel was filled with colored physiological saline solution and pressurized at 2kgf/cm.As a result, no leakage to the gas channel 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 for the involved product code/lot number combination.Based on the results of the investigation, no leakage was confirmed in the actual sample.As for the cause of occurrence, based on the provided video, it was inferred that a plasma leak occurred.From our experience, the cause of the plasma leak in the actual sample was considered as follows, however, it could not be clarified.It was considered probable that some changes in blood properties caused the production of surfactant substances and the 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 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 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved." this report is for the second device reported, for the first device reported that was used on the same patient see mdr 9681834-2022-00201.(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: 15614194
• MDR Text Key: 307265751
• Report Number: 9681834-2022-00200
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 220510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• 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
• Treatment: QUANTUM
• Patient Sex: Male