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

Catalog Number CX-FX25W

Device Problem Increase in Pressure (1491)

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

Event Date 01/17/2022

Event Type  malfunction  

Event Description

The user facility reported that after the start of the capiox oxygenator, it was circulated at ci 2.6l.The pressure was continuously increased (pressure loss of 200 mmhg or more) after about 1 hour and 40 minutes.The peak was 478 mmhg two and a half hours after the start.At this time, the post oxygenator pressure was 211 mmhg (pressure loss: 267 mmhg).Since the operation was going well, the operation was completed without replacing the oxygenator.The procedure outcome was not reported, however the patient was not harmed.

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 upon receipt did not find any anomaly such as a breakage in its appearance.After the saline solution was flowed into the actual sample by a head, visual inspection of the gas transfer section was performed.As a result, the formation of blood clot was found.From the shape of blood clot formed from the bottom to the back, it was inferred that the blood clot was formed from the time the actual sample was stored to the time it was returned.After filling the saline solution containing glutaraldehyde solution in the actual sample and fixing, the housing and filter were removed, and visual inspection of the gas transfer section was performed.As a result, the formation of blood clot was found.No anomaly was found in the winding state of the fiber.After inspection of the actual sample, the fiber layer was removed, and visual inspection of the gas transfer section was performed.As a result, the formation of blood clot was found.No anomaly was found in the winding state of the fiber.The outer cylinder was removed from the actual heat exchanger, and visual and magnifying inspections of the heat exchanger was performed.As a result, the formation of blood clot was found.Electron microscopic inspection of the actual fiber found that blood cell components such as red blood cells or deformed red blood cells (echinocyte formation) had been adhered and fibrin nets had been formed.The pump record was confirmed and following results were obtained.The main flow rate during circulation was almost constant (approximately 2.6l/min/m2).The pressure loss of the oxygenator (pre oxygenator - main circuit internal pressure) at the start of circulation was 22 mmhg, and then gradually increased.The temperature was lowered at the same time as the start of circulation, but the pressure loss of the oxygenator continued to increase even when the temperature was constant at the lower limit (between 12:00 and 13:20).Review of the manufacturing history record and the product release decision control sheet of the actual sample confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination.Ifu states: "do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings) adequate heparinization of the blood is required to prevent it from clotting in the system.(warnings)" based on the investigation result, the formation of blood clot was found in the oxygenator.In addition, as a result electron microscopic inspection of the red blood clot formed on the filter and fiber, it was found that blood cell components such as red blood cells or deformed red blood cells (echinocyte formation) were adhered and fibrin nets was formed.As a cause of occurrence, it was inferred that pressure loss increased due to the formation of blood clots for some reason.However, it was not possible to clarify the cause of the formation of blood clot from the investigation of actual sample.(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: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13534915
• MDR Text Key: 287898290
• Report Number: 9681834-2022-00009
• 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: 05/31/2024
• Device Catalogue Number: CX-FX25W
• Device Lot Number: 210601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• 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: 06/01/2021
• 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