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

Catalog Number CX-FX15RW40

Device Problem Pressure Problem (3012)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6). The actual device was returned for evaluation. Visual inspection of the actual sample upon receipt did not find any obvious, such as a break, in the appearance. Saline solution was let to flow into the blood pathway from the blood inlet port by gravity drop. It was found to flow out of the blood outlet port only in a small amount "tricklingly. " subsequently, the oxygenator module was subjected to another visual inspection. The presence of clots was found in the inside. It is difficult to determine when the clots formed, whether during use or during transportation back to the factory. The actual sample was fixed with glutaraldehyde solution and the housing component and filter were removed from it. Visual inspection of the filter found the presence of clots on the both sides. Visual inspection of the oxygenator module found the presence of clots on the fiber. The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection. The presence of clots was found on each layer. The outer cylinder was removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual and magnifying inspections. Red thrombus was found to have formed on and between the grooves. The filter removed from the oxygenator module in the test above and was inspected under magnification. The formation of red thrombus was found on it. The diameter of the mesh was confirmed to be normal. The fiber layers removed from the oxygenator module in the test above was inspected under magnification. The formation of red thrombus was found on them. Electron microscopic inspection of the filter removed from the oxygenator module in above test revealed the formation of fibrin net and the adhesion of blood cell components, including red blood cells, deformed red blood cells (echinocyte) and white blood cells, on the both sides. Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding removed from the oxygenator module in above test revealed the formation of fibrin net and the adhesion of blood cell components, including red blood cells, deformed red blood cells (echinocyte) and white blood cells. The red thrombus adhering to the heat exchanger module was collected and inspected under electron microscope. The adhesion of blood cell components, including red blood cells, deformed red blood cells (echinocyte) and white blood cells was revealed. A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no relevant findings. A search of the complaint file found no previous report of this nature with the involved product code/lot number combination. During the evaluation of the actual sample, the formation of red thrombus was found on the filter, fiber, and on the heat exchanger module. Electron microscopic inspection of the red thrombus revealed the presence of the fibrin net and the blood cell components, including red blood cells, deformed red blood cells (echinocyte), and white blood cells. 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 on the available information, it is likely that red thrombus formed inside the oxygenator module of the actual sample due to some factor(s) led to the reported rise in the pressure inside the oxygenator module. From the available information, however, it is difficult to determine the cause of the formation of red thrombus. The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: adequate heparinization of the blood is required to prevent it from clotting. Do not reduce heparin during circulation. Otherwise, blood clotting might occur. (b)(4).

Event Description

The user facility reported an increase in the pressure drop in the capiox device during a procedure. Follow up communication with the user facility confirmed the following information: within the first six minutes after the initiation of the circulation, an increase in the pressure was noted. As the high pressure seemed to be persistent, the doctor decided to stop the pump. The actual sample was changed out to a competitor's oxygenator (quadrox). Blood loss was reported to be 150 ml. The procedure outcome is unknown. There is no known patient impact.

• 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: 7045944
• MDR Text Key: 92529778
• Report Number: 9681834-2017-00242
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2020
• Device Catalogue Number: CX-FX15RW40
• Device Lot Number: 170518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/20/2017 Patient Sequence Number: 1