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 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

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.Healthcare professional - unknown.Occupation - clinical engineer.Pma/510(k)- k130520.The actual device was returned for investigation.Visual inspection of the actual sample found no breakage or other anomaly in the appearance.The gas-in side and gas-out side of the fiber bundle had been discolored into red.The gas channel was blown with air.As a result, foamy liquid leaked from the gas-out side.The liquid was tested with protein test paper ("uriace" from terumo), and the presence of protein was confirmed.Subsequently, the liquid was checked with a blood cell analyzer.Blood cells (white blood cells, red blood cells, and platelets) were found to be below the measurement limit.Therefore, this liquid was considered to be plasma which might have become light red due to hemolysis.After the actual sample was cleaned, it was filled with physiological saline solution, and then pressurized at 2kgf/cm2.As a result, no liquid leakage into the gas channel was observed.Review of the manufacturing record and product-release judgement record of the involved product/lot number combination confirmed there was no indication of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.Based on the investigation results above, it was confirmed that there was no blood leakage; however, plasma leak had occurred in the actual sample.As a cause of occurrence of the plasma leak, the possibility below can be inferred based on our experience; however, the definitive cause of the plasma leak in this complaint cannot be determined.Due to a change in the blood properties, a surface-active substance might have been generated in blood.This might have caused the balance of the surface tension between the gas and blood, which had been kept at the micro pores on the surface of the fibers, to be disrupted, resulting in a condition where plasma leak tended to occur.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 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that during extracorporeal circulation of the capiox fx25 device involved, a reddish liquid was observed leaking from the gas-out port.The patient had been on ecc for a long time (approximately six hours) and there was a possibility of a plasma leak.Due to the leak occurring before weaning, the ecc was continued as it was.Since the liquid appeared slightly reddish, it could not be determined whether it was a plasma leak or a blood leak.The investigation was requested.There was no patient injury, and no medical or surgical intervention was required.The final patient impact was not harmed.The event occurred intra-operative.

• 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: 15129224
• MDR Text Key: 304374566
• Report Number: 9681834-2022-00154
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX38703A
• Device Lot Number: 220125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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