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

Catalog Number CX-FX25RWV

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual sample was received for evaluation.Visual inspection revealed that some blood clots had formed around the cardiotomy filter and venous filter.No physical damage, such as a break, was observed in the appearance.The venous filter was removed from the reservoir, and then the venous filter and the defoamer inside it were subjected to visual inspection after submerged in physiological saline solution.No blood clot was found to have formed on the inner surface of the venous filter or on the defoamer.The cardiotomy filter was removed from the reservoir, and then the cardiotomy filter and the defoamer inside it were subjected to visual inspection after submerged in physiological saline solution.Some blood clots were found to have formed on the inner surface of the cardiotomy filter as well as on the inner surface of the defoamer.Visual inspection of the oxygenator sample did not find any anomaly, such as a break, in the appearance; after flushed with physiological saline solution poured by gravity did not find any visible blood clot formation inside it.The inside of the oxygenation module was fixed by being filled with glutaraldehyde-containing saline solution.Then, the housing and the filter were removed and subjected to visual inspection.No visible blood clots were found to have formed on the outer or inner surfaces of the filter.The oxygenation module was visually inspected; no visible blood clots were found to have formed, the state of the fiber winding was confirmed to be normal.The fiber layer was removed from the winding in increments of 2mm and each layer was subjected to visual inspection.No blood clots were found to have formed.The outer cylinder was removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual and magnifying inspections.No blood clots were found to have formed.Both sides of the filter that had been removed were inspected under magnification.No blood clots were found to have formed.The fiber layers removed from the upper and bottom sides were inspected under magnification.No blood clots were found to have formed.To visualize the flow behavior in the actual reservoir sample, the following test was conducted: physiological saline solution was circulated in a factory-retained sample at the flow rate of 4l/min.With the liquid level in the reservoir kept at 3000ml.During the circulation, 100ml of india ink was poured into the reservoir from one of the ports on the cardiotomy filter, while the flow behavior of the india ink was observed.The india ink was found to stagnate around the venous filter.(*the circulation conditions were set optionally in this test.) a review of the device history record and product release decision control sheet of the 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 is likely that terumo's reservoir is designed to have the structure that allows the level of blood reserved in it to be kept stable and to be controlled easily; due to such a structure, it may become difficult for blood to be better agitated in the reservoir.Blood in which coagulation factors had been activated was flowed into the reservoir and stagnated on the solution level, leading to the clot formation.However, 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 during preparation of the capiox device, for weaning the patient from ecc, when they started reducing the blood volume in the reservoir, a large quantity of blood clots were found to have formed on the surface of the venous filter.As the blood volume in the reservoir was being reduced, the blood clots peeled off and fell.Blood clots were found to have formed also in the cardiotomy filter.The oxygenator was not changed out.The procedure was completed successfully, and 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 9346588
• MDR Text Key: 205522300
• Report Number: 9681834-2019-00200
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: CX-FX25RWV
• Device Lot Number: 190724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• 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