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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, 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 Key7045944
MDR Text Key92529778
Report Number9681834-2017-00242
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071494
Number of Events Reported1
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 Received11/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberCX-FX15RW40
Device Lot Number170518
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2017
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
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