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

Catalog Number CX-XRX18331

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device was received for evaluation.Visual inspection revealed some thrombi adhering to the cardiotomy filter (cr filter).There were no visual anomalies 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 thrombi 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 thrombi was found on the inside surface of the venous filter.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 thrombi adhering to the surface of the cr filter were sampled and inspected under electron microscope.The presence of the blood corpuscle components, including red blood cells, deformed red blood cells (echinocytes) and white blood cells, was revealed.The oxygenator module was inspected and visual inspection with the naked eye did not find anomalies.Physiological saline solution was let to flow through the oxygenator module was flashed by gravity.Subsequent visual inspection found the presence of red thrombi formed at the bottom area 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, did not find any thrombus visible with the naked eye.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.There was no thrombus visible with the naked eye.The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections.The formation of thrombus was found on it.Magnifying inspection of the both sides of the filter removed from the oxygenator revealed the formation of red thrombus on them.There was no anomaly in the diameter of the mesh of the filter.Magnifying inspection of the fiber layers removed from the oxygenator module in no.5 revealed thin red thrombi formed all over the fibers.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 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 thrombi adhering to the surface of the bottom area of the heat exchanger were sampled and inspected under electron microscope.The presence of blood corpuscle components, including deformed red blood cells(echinocytes) and the formation of fibrin net were revealed.A review of the device history record and shipping inspection 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.During the above investigation, the formation of thrombi was found on the cr filter, venous filter and the defoamers housed inside the venous reservoir.The formation of thrombi was also found on the filters and heat exchanger housed inside the oxygenator module.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.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 capiox device was used on a patient with hit (heparin-induced thrombocytopenia).During the extracorporeal circulation, thrombi which were visible with the naked eye formed inside the device.With no decrease in the flow rate or no increase in the pressure, the extracorporeal circulation was continued and completed without any problem.The oxygenator was not changed out.There was no blood loss 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, 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; 950 elkton blvd; elkton, MD 21921
• MDR Report Key: 7549757
• MDR Text Key: 109627000
• Report Number: 9681834-2018-00090
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: CX-XRX18331
• Device Lot Number: 180312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• 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