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

Catalog Number CX-FX25RW

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age and date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Udi - not required for this product code/ lot number combination.Implanted date: device was not implanted.Explanted date: device was not explanted.The 510k - k130520.The actual device has been returned for evaluation.Visual inspection of the reservoir revealed no defects.The reservoir was disassembled into each component.The cr filter and the defoamer was taken out of the cr filter, after having blood rinsed off with physiological saline solution, were fixed with glutaraldehyde solution for visual inspection.The formation of red thrombus was found on the cr filter.The cr filter and defoamer were electron microscopically inspected.The adhesion of the erythrocyte components, including red blood cells and platelets were revealed.There was no anomaly in the state of the filter meshes of the cr filter or defoamer.The venous filter and the defoamer taken out of the venous filter were soaked in physiological saline solution and fixed with glutaraldehyde solution for visual inspection.No formation of thrombus visible to the naked eye was revealed.The venous filter and defoamer were electron microscopically inspected.The adhesion of the erythrocyte components, including red blood cells and platelets were revealed.There was no anomaly in the state of the filter meshes of the cr filter or defoamer.Visual inspection of the oxygenator revealed no defects.Physiological saline solution was flowed through the actual device by gravity drop.Subsequent visual inspection with naked eye found the formation of red thrombus inside the device.The actual device was fixed with glutaraldehyde solution and the housing component and the filter were removed for further inspection of the inside of the oxygenator module with the naked eye.The formation of red thrombus was found on the surfaces of the filter.Subsequently the inside of the oxygenator module was inspected with the naked eye.No visible thrombus formation was found.The fiber was found to have been wound in the proper manner.The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection with the naked eye.No visible thrombus formation was found.After all the fiber layers and the outer cylinder were removed and the heat exchanger module was subjected to visual and magnifying inspections.There was no visible thrombus formation revealed.The both sides of the filter removed during the above test were inspected under magnification.The formation of thrombus was found on the surfaces.The diameter of the mesh of the filter was confirmed to be normal.The fiber layers removed during the above test were inspected under magnification.There was no visible thrombus formation revealed.Electron microscopic inspection of the outer and inner surfaces of the filter revealed the adhesion of erythrocyte components, including red blood cells, white blood cells and platelets and the formation of fibrin net.Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding obtained in above test revealed the adhesion of erythrocyte components, including red blood cells, echinocytes, white blood cells and platelets and the formation of fibrin net.There is no evidence that this event was related to a device defect or malfunction.During the above investigation, the formation of red thrombus was found on the cr filter housed in the reservoir of the actual sample.Electron microscopic inspection revealed the adhesion of erythrocyte components, including red blood cells, white blood cells and platelets and the formation of fibrin net on each component of the reservoir and oxygenator module of the actual sample.From the available information, however, it is difficult to determine the definitive cause of the reported thrombus formation.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.Follow up communication with the user facility confirmed the following information: during the procedure, blood coagulation was noted in the cardiotomy filter.The actual device was not changed out and the procedure was completed with the actual sample.The procedure outcome is unknown.It was reported that 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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7205134
• MDR Text Key: 98066840
• Report Number: 9681834-2017-00267
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: CX-FX25RW
• Device Lot Number: 170904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2017
• 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