MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX05RE

Device Problem Increase in Pressure (1491)

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

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.Pma/510(k)- k130280.The actual sample was received for evaluation.Visual inspection revealed no breakage or other anomaly in the appearance.The actual sample was built into a circuit with tubing, and normal saline was flowed by head.The flow rate of the normal saline flowing out from the actual sample was found lower than that from a current product, which suggested that a clogging had occurred.The oxygenation module of the actual sample was inspected visually, and a formation of fiber-like blood clots was confirmed.The actual sample was fixed by being filled with glutaraldehyde-containing normal saline, and then the housing and the filter were removed.Visual inspection of the oxygenation module found no formation of blood clots that could lead to the increasing pressure.The oxygenation module was visually inspected while the fiber layer was removed gradually.Formation of blood clots was observed on the fiber near the heat exchanger.No anomaly was noted in the winding state of fiber.The heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspections.Formation of white clots was observed.The filter and fiber were inspected under an electron microscope; formation of fibrin net and adhesion of red blood cells, deformed red blood cells (echinocyte), platelets and other blood cell components were observed.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It was likely that the cause of occurrence was conceivable to be the following factors because the clogging occurred 20 minutes after the start of circulation and the circulation temperature was lowered.The blood with activated aggregation of leukocytes and platelets might have flowed into the oxygenator and caused clogging of the oxygenator, resulting in the increasing pressure drop.The cold agglutination might have caused the blood flow to be obstructed and the pressure drop to increase.However, it was not possible to clarify the definite cause of activation of leukocyte and platelet aggregation and the cause of clogging.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the capiox device was used during the procedure.The oxygenator pressure increased.Pressure increased in about 20 minutes after the pump was on.When the inlet pressure was 300 mmhg and the outlet pressure was 150 mmhg, they started to be a little concerned, increased the number of venous lines from one to two and increased the flow rate, and then checked the pressure again.The inlet pressure was 400 mmhg and the outlet pressure was 100 mmhg, so they replaced the actual sample with a new fx05 using a line for the oxygenator exchange.The procedure completed successfully.The patient was not harmed.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12949938
• MDR Text Key: 282280691
• Report Number: 9681834-2021-00225
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: CX-FX05RE
• Device Lot Number: 210610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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
• Patient Outcome(s): Other