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

Catalog Number CX-FX15RE30V

Device Problem Increase in Pressure (1491)

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

Event Date 08/02/2021

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)- k130520.The actual sample was received for evaluation.Visual inspection upon receipt did not find a breakage or other anomaly in the appearance.The actual sample was rinsed with normal saline flowed by head, and then the oxygenation module was inspected visually.Formation of blood clots was observed.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 formation of blood clots.Based on the shape of the blood clots formed on the back side, it was thought there was a possibility that the clots may have formed between the time the actual sample was stored and the time it was returned.The oxygenation module was visually inspected while the fiber layer was removed gradually.A slight blood clots were observed.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.No deformity or other anomaly that could lead to a formation of blood clots or clogging was observed in the heat exchanger.The filter and fiber were inspected under an electron microscope.Adhesion of red blood cells deformed red blood cells (echinocyte), platelets and other blood cell components, and fibrin net formation was 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 pressure increased due to the formation of blood clots and echinocyte.However, the exact timing of the formation of blood clots or the factors of the echinocyte or the aggregation of platelets could not be clarified, the definite cause of the increasing pressure could not be clarified.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 avr case.The pressure was high from the start, pre-oxygenator pressure was about 450 mmhg.Although the pressure was high until pump was off, the pressure was controlled at around 400-410, and the procedure was successfully completed.The patient was not harmed.

• Brand Name: CAPIOX FX 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: mary o'neill ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 12376448
• MDR Text Key: 268493272
• Report Number: 9681834-2021-00146
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2021

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: 12/31/2023
• Device Catalogue Number: CX-FX15RE30V
• Device Lot Number: 210112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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