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

Catalog Number CX-XRX09903

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Information (3190)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k): k130520.The actual device was received for evaluation.Visual inspection revealed some clots adhering to the cardiotomy filter (hereinafter called cr filter in this report) and the venous filter.There was not any visible obvious anomaly, such as a break, in the appearance.The reservoir was disassembled into each component.The cr filter and the defoamer were taken out of the cr filter, after having been rinsed in physiological saline solution, were subjected to visual inspection.The presence of clots was noted on them.The venous filter and defoamer were taken out of the venous filter, after having been rinsed in physiological saline solution, were subjected to visual inspection.The presence of clots was found on them.The cr filter and defoamer were fixed with glutaraldehyde solution for further inspection.Electron microscopic inspection revealed the formation of the fibrin net and the adhesion of blood corpuscle components, including red blood cells and deformed red blood cells(echinocytes), on them.The venous filter and defoamer were fixed with glutaraldehyde solution for further inspection.Electron microscopic inspection revealed the formation of the fibrin net and the adhesion of blood corpuscle components, including red blood cells and deformed red blood cells(echinocytes), on them the clots adhering to the surface of the venous filter and the cr filter were sampled.The electron microscope inspection of the clots revealed the formation of the fibrin net and the presence of blood corpuscle components, including red blood cells and deformed red blood cells(echinocytes).Visual inspection of the oxygenator module with naked eye upon receipt did not find any obvious anomaly, such as a break, in the appearance.The actual device was flushed with saline solution by gravity drop.Subsequent visual inspection found the presence of clots on the bottom area.The actual device was fixed with glutaraldehyde solution and the housing component and the filter were removed from the oxygenator module.Visual inspection of the filter removed from the oxygenator module found the formation of clots on the outer surface.Visual inspection of the oxygenator module, after the housing component and the filter having been removed from it, did not find any clots on it.There was no anomaly in the state of fiber winding.The fiber layers were removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.Red thrombus was found to have formed on the fiber layers near the heat exchanger module.The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections.The formation of clots was found on the bottom area.Magnifying inspection of the both sides of the filter removed from the oxygenator module revealed the formation of clots on the partial area on the outer surface.Magnifying inspection of the fiber layers removed from the oxygenator module revealed the formation of red thrombus on them.Electron microscopic inspection of the outer and inner surfaces of the filter removed from the oxygenator module revealed the formation of fibrin nets on them and the adhesion of blood corpuscle components, including red blood cells and deformed red blood cells(echinocytes), to them.Electron microscopic inspection of the upper segments of the fiber layers removed from the oxygenator module revealed the formation of fibrin nets on them and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells (echinocytes) and blood platelets, to them.A review of the device history record of the involved product code/lot number combination revealed no findings.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported the involved capiox custom pack was used during the procedure.Argatroban was administered to the hit patient before starting the extracorporeal circulation.After that, in spite of continued administration of nafamostat mesilate, clot formation occurred during the circulation.The procedure was completed successfully without changing out the actual sample.There were no other devices or equipment used with the reported device.The patient impact was reported to be unknown.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8343281
• MDR Text Key: 139456559
• Report Number: 9681834-2019-00015
• 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: 02/15/2019

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: 04/30/2020
• Device Catalogue Number: CX-XRX09903
• Device Lot Number: 181109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2018
• 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