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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-FX25E
Device Problem Increase in Pressure (1491)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2019
Event Type  malfunction  
Manufacturer Narrative
Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. 510(k): k130520. The actual sample was returned for evaluation. Visual inspection revealed no anomalies, such as a break, in the visual appearance. Saline solution was let to flow through the actual device by gravity. Subsequent another visual inspection did not find any clot formation visible with the naked eye. The actual device was built into a circuit with tubes. Saline solution was circulated in it and the pressure drop was determined at each flow rate. The pressure drop was found to be equivalent to than that of the current product sample. The actual device was filled with saline solution containing glutaraldehyde solution to be fixed and the housing component and filter were removed. Visual inspection of the outer and inner surfaces of the filter did not find any clot formation visible with the naked eye. Visual inspection of the oxygenator module did not find any clot formation visible with the naked eye. The state of the fiber winding was confirmed to be normal. The fiber layer was removed from the winding in increments of 2mm and each layer was subjected to visual inspection. There was no clot formation on the fiber layers visible with the naked eye. 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. There was no clot formation on it. The outer and inner surfaces of the filter that were removed, were inspected under magnification. There was no clot formation on them. The diameters of the mesh were confirmed to be normal. The fiber layers that were removed, were inspected under magnification. There was no clot formation on them. Electron microscopic inspection of the outer and inner surfaces of the filter revealed the adhesion and agglutination of the blood corpuscle components, including blood platelets. Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding revealed the adhesion of the blood corpuscle components, including blood platelets, red blood cells and white blood cells, in a slight amount. There was no clot formation which could have be a trigger of a pressure rise. A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with 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 investigation results verified the returned sample was of the normal product. 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 at the beginning of use of the capiox device, the pressure at the inlet port started to rise gradually up to 450mmhg at the maximum. With no further rise seen in the pressure, the customer continued to use the actual sample until the end of the surgery. The patient was not harmed.
 
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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
950 elkton blvd
elkton, MD 21921
8002837866
MDR Report Key8959588
MDR Text Key157867822
Report Number9681834-2019-00153
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 09/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Catalogue NumberCX-FX25E
Device Lot Number190402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2019
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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