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

Catalog Number CX-XRX49103

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

Udi number - this product code is not required to be registered with the fda. The actual device was returned to the manufacturing facility for evaluation. Visual inspection found no visible break on the device. The actual device, after having been rinsed with saline solution, was fixed with glutaraldehyde solution and the housing component was removed for further inspection of the gas transfer part. Some clots were found to have formed there. The filter was removed for further inspection of the gas transfer part. The clots were found to have formed mainly on the back side of the device. The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection. There was no visible thrombus formation noted. Magnifying inspection of the filter removed from the oxygenator found some clots had formed. The fiber layers removed from the upper area of the oxygenator were inspected under magnification. Some clots were found to have formed on the surface of each layer. After the fiber layer was removed, the outer cylinder of the heat exchanger module was subjected to visual inspection. No clot formation visible to the naked eye was found. The outer cylinder was removed and the inside of the heat exchanger module was subjected to magnifying inspection. No clot formation was found. A picture provided by the user facility noted membrane like clots to be adhering inside of the reservoir. A review of the device history record of the involved product code/lot number combination was conducted with no relevant findings. A search of the complaint file found no other report with the involved product code/lot number combination. There is no evidence that this event was related to a device defect or malfunction. Although the exact cause of the reported event cannot be definitively determined based upon the available information, a potential cause of the reported clot formation inside the reservoir is blood in which coagulation factors had been activated may have flowed into the reservoir and stagnated on the solution level, leading to the clot formation. The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: "do not reduce heparin during circulation. Otherwise, blood clotting might occur. Adequate heparinization of the blood is required to prevent it from clotting in the system. " (b)(4). All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported formation of clots in the capiox device. Follow up communication with the user facility confirmed the following information: the customer found some clots formed inside the reservoir after the pump was off. Flow out of the clots into the oxygenator module was doubted. The actual device was not changed out. Conditions: act was > 200 seconds and the fluid level in the reservoir was around 100ml. The procedure was completed successfully. 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5987773
• MDR Text Key: 55999866
• Report Number: 9681834-2016-00232
• 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

• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2017
• Device Catalogue Number: CX-XRX49103
• Device Lot Number: 151118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial