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

Catalog Number CX-FX15RW40V

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

Udi - not required for product code implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k): k130520.The actual device was received for investigation.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, and 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 the outer and inner surfaces.There were not any clots on the defoamer.The cr filter and defoamer were fixed with glutaraldehyde solution for further inspection.Electron microscopic inspection revealed the formation of the fibrin net, 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 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).The oxygenator module was visually inspected with the naked eye and revealed no obvious anomalies.The actual device was flushed with saline solution by gravity drop.Subsequent visual inspection found the presence of some clots.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 both surfaces.Visual inspection of the oxygenator module, after the housing component and the filter having been removed from it, found the presence of some clots on the filter.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.Clots was found to have formed thinly on the surface of the fiber layers located on the upper and bottom sides near the heat exchanger module.The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections; clot formation was not found.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 did not reveal any clot formation 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.The ifu states: adequate heparinization of the blood is required to prevent it from clotting in the system.Do not reduce heparin during circulation.Otherwise, blood clotting might occur.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation, it is likely that the clots formed due to some factor(s) caused the reported rise in the pressure and drop in the flow rate.However, based off the available information the exact cause of the reported event cannot be definitively determined.(b)(4).

Event Description

The user facility reported that during the circulation of the involved capiox device, the operator noticed some clots formed inside the reservoir.Suddenly, the pressure before the membrane became high with a drop in the flow rate.Heparin was added and recirculation was carried out and the issues disappeared.The amount of blood loss and patient impact was reported to be unknown.The procedure was completed successfully.

• 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: 8355324
• MDR Text Key: 136742078
• Report Number: 9681834-2019-00022
• 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: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CX-FX15RW40V
• Device Lot Number: 181029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2019
• Date Device Manufactured: 10/29/2018
• 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
• Patient Outcome(s): Other