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 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

Health professional: unknown.Occupation: others.Pma/510(k)- k130520.The actual sample was discarded by the involved facility.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the provided movie confirmed that the gas-out port was leaking transparent fluid.Review of the manufacturing record and the product-release judgment record of the actual sample confirmed there was no anomaly in them.A search of the complaint record found no similar report regarding the involved product code/lot combination.No anomaly was confirmed in the manufacturing related records.As a cause of occurrence of the plasma leak, the possibilities below can be inferred based on our experience; however, the definitive cause of the plasma leak in this complaint cannot be determined from the above investigation results.Due to a change in the blood properties, a surface-active substance may have been generated in blood.This may have led the balance of the surface tension between the gas and blood, which is kept at the micro pores on the surface of the fibers, to be upset, and the fibers may have got hydrophilized, resulting in the plasma leak.Increasing pressure in the circuit due to some factors, such as clotting, may have caused the pressure applied from the blood channel to the gas channel to get increased.This may have increased force to push the blood corpuscle components out into the gas channel, resulting in the 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 15 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.(d.During perfusion, warning)" (b)(4).

Event Description

The user facility reported that during cardiopulmonary bypass (cpb) the perfusionist observed the froth formation (membrane leak) inside the oxygenator chamber.There was also reduced oxygenation during cpb.The oxygenator was not replaced, and the procedure was continued as normal.No event was reported.The final patient impact was not harmed.There was no patient injury or medical/surgical intervention required.

• 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: 15051163
• MDR Text Key: 304715005
• Report Number: 9681834-2022-00143
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: 04987350701169
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Other
• Type of Report: Initial
• Report Date: 07/19/2022

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 Model Number: N/A
• Device Catalogue Number: CX*FX15RW30
• Device Lot Number: 220304
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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 Age: 5 YR
• Patient Sex: Male
• Patient Weight: 11 KG