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

Catalog Number CX-XRX31004

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

The actual device was returned for evaluation.Visual inspection of the reservoir found some clots adhering to the venous filter and the cardiotomy filter (hereinafter called cr filter in this report).There were no visible anomalies or defects.The reservoir was disassembled into each component.The cr filter and defoamer taken out of the cr filter, after having been rinsed in physiological saline solution, then 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 adhesion of blood corpuscle components, including red blood cells, deformed red blood cells(echinocytes) and blood platelets, to them.The meshes of the cr filter and defoamer were confirmed to be in the normal state.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 venous filter and defoamer were fixed with glutaraldehyde solution for further inspection.Electron microscopic inspection 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.The meshes of the venous filter and defoamer were confirmed to be in the normal state.The clots adhering to the surface of the defoamer of the venous reservoir was sampled and inspected under electron microscope.The presence of the formation of fibrin nets and red blood cells and deformed red blood cells(echinocytes) was revealed.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 oxygenator module was built into a circuit with tubes.Physiological saline solution was filled and circulated in the circuit.The pressure drop was determined at each flow rate.The obtained values were found to be higher than those of the current product sample.Visual inspection after the above test, found the formation of red thrombus inside the device.The actual device was fixed with glutaraldehyde solution and the housing component and filter were removed from the oxygenator module.Visual inspection of the filter removed from the oxygenator module found the formation of red thrombus on the outer and inner surfaces.Visual inspection of the oxygenator module, after the housing component and filter having been removed from it, found the formation of thin film-like red thrombus covering the entire surface of the fibers.There was no anomaly in the state of fiber winding.The fiber layer was 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 entire fiber layers.The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections.The formation of red thrombus was found on it.Magnifying inspection of the both sides of the filter removed from the oxygenator module in the above test revealed the formation of red thrombus on them.There was no anomaly in the diameter of the meshed of the filter.Magnifying inspection of the fiber layers removed from the oxygenator module in the above test 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, deformed red blood cells(echinocytes) and blood platelets, to them.Electron microscopic inspection of the upper segments of the fiber layers removed from the oxygenator module in the above test 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.The red thrombus adhering to the surface of the upper segment of the heat exchanger was sampled and inspected under electron microscope.The presence of blood corpuscle components, including red blood cells and deformed red blood cells(echinocytes) was revealed.There is no evidence that this event was related to a device defect or malfunction.During the investigation, the formation of red thrombus was found on the defoamer housed inside the venous filter of the reservoir.Electron microscopic inspection of each component of the reservoir and oxygenator module revealed the formation of fibrin nets on it and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells(echinocytes) and blood platelets, to it.As a cause of this complaint, it is likely that the clots formed inside the actual device due to some factor(s) led the pressure inside the device to rise.From the available information, however, the cause of the clot formation cannot be determined.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.(b)(4).

Event Description

The user facility reported clots with the capiox device.During the avr case with the circulation time 190 minutes.There was no issue during the circulation.After the circulation, the customer tried to send residual blood to the oxygenator, when he found some clots inside the reservoir.He changed it out.The pressure inside the oxygenator was found to be too high to send blood to it.The oxygenator module was also changed out immediately.The amount of blood loss is unknown.The procedure outcome is unknown.Final patient impact is 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7489887
• MDR Text Key: 107448561
• Report Number: 9681834-2018-00059
• 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
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: CX-XRX31004
• Device Lot Number: 180124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• 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