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

Catalog Number CX-FX05RW

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was returned for evaluation.Visual inspection revealed no anomalies in appearance.Saline solution was let to flow through the actual device by gravity.Another visual inspection of the actual device did not find any clot formation visible to the unaided eye.The actual device was fixed with saline solution containing glutaraldehyde solution.The housing and filter were removed from the oxygenator module.Visual inspection of the filter did not find any clot formation visible to the unaided eye either on the outer or inner surface.Visual inspection of the oxygenator module, after the housing and filter having been removed from it, did not find any clot formation visible to the unaided eye on the fiber.The fiber winding was confirmed to be in the normal state.The fiber layer was removed from the winding in increments of 2mm and each layer was subjected to visual inspection.There was no clot formation visible to the naked eye on the fiber.The fiber and the outer cylinder were removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual and magnifying inspections.Clot formation was found at the bottom of the device.The filter removed from the oxygenator module was inspected under magnification.No clot formation was confirmed.The fiber layers removed during the test in above were inspected under magnification.No clot formation was confirmed.The filter was inspected under electron microscope.The formation of the fibrin net and the adhesion of the erythrocyte components, including red blood cells, deformed red blood cells (echinocyte) and platelets were found on the surface.Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding obtained in above did not find clot formation which could have contributed to the reported pressure rise.The clot found to have formed at the bottom of the heat exchanger module was sampled and inspected under microscope.The adhesion of the erythrocyte components and the formation of the fibrin net were found.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.During the inspection of the actual device, clots were found to have formed at the bottom of the heat exchanger module.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported after priming with bicarbon (bicarbonate ringer's solution) and heparin, blood for transfusion was put into a competitor's reservoir and ultrafiltration was performed.After 1-hour circulation in the recirculation line, thrombus formation was found in the competitor's reservoir and the pressure inside the actual sample increased.Both the reservoir and the actual sample were changed out.The procedure outcome was reported to be unknown.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: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921
• MDR Report Key: 7977128
• MDR Text Key: 124665097
• Report Number: 9681834-2018-00187
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CX-FX05RW
• Device Lot Number: 180511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2018
• 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