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

Catalog Number CX-XRY07855

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual device was returned for evaluation.Visual inspection revealed that there were no obvious anomalies.The actual device was filled and fixed with saline solution containing glutaraldehyde solution for further inspection.Visual inspection found some clots forming inside.The housing was removed.Some clots were found to have formed on the surface of the filter.The filter was separated from the oxygenator module and subjected to visual inspection; some clots were found on both surfaces.Visual inspection of the actual device, after the housing component and the filter having been removed from it, did not find any clots which were visible with the naked eye on the fiber.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; with the following findings: after 2mm was removed, clots were found to have formed on the bottom phase; after 4mm was removed, clots were found to have formed on the bottom phase; after 6mm was removed, clots were found to have formed on the bottom and back phases; after 8mm was removed, clots were found to have formed on the bottom and upper phases; after 10mm was removed, the entire surface of the fiber appeared to have become reddish in color; after 12mm was removed, white thrombus which was visible with the naked eye was found to have formed on the upper phase; after 14mm was removed, clots were found to have formed circumferentially on the surface of the fiber.On each layer of the fiber more clots were found on the bottom phase than on other phases.With a small amount of blood pooled in the bottom phase found upon received of the actual device taken into consideration, it is likely that the blood remaining inside the actual sample had transformed into the clots observed during this inspection.The outer cylinder was removed, and the heat exchanger module was subjected to visual and magnifying inspections.White thrombus was noted to have formed on the upper and back phases.Magnifying inspection of both surfaces of the filter removed from the actual device revealed the formation of white thrombus on both surfaces.Magnifying inspection of the fiber layers removed from the oxygenator module revealed the formation of white thrombus.The closer the fiber layer came to the heat exchanger module; the more clots were found to have formed.Electron microscopic inspection of the outer and inner surfaces of the filter removed from the oxygenator module revealed adhesion and aggregation of blood corpuscle components, including blood platelets and white blood cells on them.Electron microscopic inspection of the upper sections of the fiber layers removed from the oxygenator module revealed formation of fibrin nets on them and adhesion of blood corpuscle components, including red blood cells, white blood cells and blood platelets, to them.Electron microscopic inspection of the clots collected from the heat exchanger module revealed aggregation of blood corpuscle components, including red blood cells, white blood cells and blood platelets.Electron microscopic inspection of the clots revealed formation of the fibrin nets and presence of blood corpuscle components, including red blood cells, blood platelets and white blood cells.A review of the device history record of the involved product code/lot number combination revealed no findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox custom pack was used during the reported event.During the extracorporeal circulation, the pressure before membrane increased up to 400mmhg.The act was being controlled at around 600 seconds.The customer decided not to change out the actual sample.The procedure was completed successfully with the use of the actual sample.The patient was no harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8771361
• MDR Text Key: 160051430
• Report Number: 9681834-2019-00122
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: CX-XRY07855
• Device Lot Number: 180926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2018
• 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