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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-XRX53402A
Device Problem Increase in Pressure (1491)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2019
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The 510k - k130520. The actual device was received for evaluation. Visual inspection with the naked eye revealed no obvious anomaly. Saline solution was let to flow through the inside of the actual device by gravity. Subsequent visual inspection of the gas transfer module found it had been discolored into pale brown. The actual device was built into a circuit with tubes and the pressure drop during circulation of saline solution at each flow rate. The obtained values were confirmed to be equivalent to those of the current product sample. The saline solution coming out of the actual device was found to have become cloudy. The actual device was filled and fixed with saline solution containing glutaraldehyde solution for further inspection. The filter was removed from the actual device for further visual inspection. It was found to have been discolored faintly on both surfaces entirely. Visual inspection of the actual device, after the housing component and the filter having been removed from it, found the fiber had been faintly discolored entirely. 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. After 2mm was removed; there was no clot visible to the naked eye, after 4mm was removed; there was no clot visible to the naked eye, after 6mm was removed; there was no clot visible to the naked eye, after 8mm was removed; there was no clot visible to the naked eye, after 10mm was removed; there was no clot visible to the naked eye, after 12mm was removed; there was no clot visible to the naked eye, and after 14mm was removed; there was no clot visible to the naked eye. The outer cylinder was removed, and the heat exchanger module was subjected to visual and magnifying inspections; no clot was found. Magnifying inspection of both surfaces of the filter removed from the actual device did not find any clot on either surface. Magnifying inspection of the fiber layers removed from the oxygenator module in revealed the formation of white thrombus partially on the fiber. Electron microscopic inspection of the outer and inner surfaces of the filter removed from the actual device 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 adhesion of blood corpuscle components, including white blood cells and a large amount of blood platelets, to them. A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings. Ifu states: adequate heparinization of the blood is required to prevent it from clotting in the system. Do not reduce heparin during circulation. Otherwise, blood clotting might occur. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. It is likely that white thrombus was formed inside the actual device due to some factor(s), resulting in the reported pressure rise during the circulation. 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 that the actual capiox custom pack was used for an arch aortic replacement. During the circulation, the pressure became high. After the operation, a decrease in the number of blood platelets was noted. The oxygenator was not changed out. The patient was not harmed, the procedure outcome was not provided.
 
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Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, 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
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key8806999
MDR Text Key151599622
Report Number9681834-2019-00127
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 Other Health Care Professional
Type of Report Initial
Report Date 07/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Catalogue NumberCX-XRX53402A
Device Lot Number190328
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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