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

Catalog Number CX-FX25W

Device Problem Leak/Splash (1354)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation-clinical engineer.Pma/510(k)- k130280.The actual device was returned for investigation.Visual inspection of the actual sample as received found no breakage or other external anomalies.Red transparent liquid was observed in the gas-in side of the housing.After the liquid was collected, air was blown into the gas channel of the actual sample.As a result, foamy liquid was observed to flow out.The foamy liquid and the red transparent liquid from the gas-in channel were analyzed and confirmed to contain protein.The collected liquid was centrifuged.As a result, no sediment of blood cell components was confirmed.From this, it was inferred that, the red liquid collected was the plasma component of the hemolysed blood leaked into the gas channel due to hydrophilization of the fiber.The actual sample after cleaned was filled with colored physiological saline solution, and then tested for leakage by air of 2kgf/cm2 being applied.As a result, no liquid leaking to the gas channel was observed.Review of the manufacturing record and the product-release judgement record of the involved product code/lot confirmed there was no anomaly in it.A search of the complaint file found no other similar report with the involved product code/lot# combination from other facilities.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 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved." based on the investigation result, it was confirmed that a plasma leak had occurred in the actual sample.In addition, it was thought that as the plasma leak had developed gradually, the oxygenation performance had deteriorated gradually.Based on our experience, the following possibility was considered as the cause of the plasma leak in this case, but the definite cause of occurrence could not be determined.Due to a change in the blood properties, a surface-active substance might have occurred in blood and disrupted the relationship, which had been maintained in the micropores of the fiber surface, between the surface tension of the blood and the gas pressure.This might have led to a condition where plasma leak was prone to occur.(b)(4).

Event Description

The user facility reported that the purpose of the procedure was thoracoabdominal blood vessel replacement.Mera was used for about 6 hours from the start of procedure, a plasma leak occurred, and it was replaced with fx25.About 3 hours after the replacement, a plasma leak occurred in the fx25 as well.Oxygenation became poor, so fio2 was increased, but oxygenation did not improve.Fx25 continued to be used with poor oxygenation.As weaning was impossible, they switched to pcps.The procedure outcome was not reported; however, the patient was not harmed.

• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13534974
• MDR Text Key: 288182710
• Report Number: 9681834-2022-00010
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 02/15/2022

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: 04/30/2024
• Device Catalogue Number: CX-FX25W
• Device Lot Number: 210520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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