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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-XRY39501
Device Problem Increase in Pressure (1491)
Patient Problem Blood Loss (2597)
Event Date 12/07/2016
Event Type  Injury  
Manufacturer Narrative
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 anomalies in the visual appearance. After having been fixed with glutaraldehyde solution, the device was further inspected with the unaided eye. A clot formation was found. Upon fixing treatment with glutaraldehyde solution, the flow of the solution was noted to be very slow. The housing and filter components were removed for visual inspection of the fibers. A clot formation was noted. There was no anomalies in the state of fiber winding. The fiber layer was removed from the winding in increments of 2 mm. Each layer was subjected to visual inspection. As the fiber layers were removed the clots became more noticeable. The heat exchanger module was inspected with the unaided eye and under magnification. White thrombus was found to have formed on the bottom and back sides. Magnifying inspection of the filter taken out of the oxygenator module revealed the clot formation on the surfaces. There was no anomalies in the diameter of the filter mesh. The fiber layers removed from the oxygenator module were inspected under magnification, clot formation was found. Electron microscopic inspection of the inside and outside surfaces of the filter revealed the formation of fibrin net and the adhesion of the erythrocyte components mainly consisting of blood platelets, white blood cells, red blood cells, and echinocytes. Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding revealed the formation of fibrin net and the adhesion of the erythrocyte components mainly consisting of blood platelets, white blood cells, red blood cells, and echinocytes. 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# combination. There is no evidence that this event was related to a device defect or malfunction. Although an exact cause cannot be definitively determined based on the investigation results, it is likely that some clots formed due to some factors, resulting in the reported increase in the pressure. The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "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. " (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 a pressure increase when using the capiox device. Follow up communication with the user facility confirmed the following information: recirculation was ongoing during the preparation of the oxygenator; to implement cannulation, heparin was administered; with no increase in act to the desirable value, another heparin was added; act was increased enough to start suctioning blood; at this stage, only the suctioned blood was being circulated inside the oxygenator; the pressure before the oxygenator started to rise; the extracorporeal circulation started; the flow rate would not reach the appropriate level, it was around 500 ml/min. @2000 rpm; the customer determined the oxygenator was obstructed and changed out to another one; blood loss was 200 ml; after this, no further issues occurred; and the patient recovered.
 
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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
jennifer suh
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key6194921
MDR Text Key63058466
Report Number9681834-2016-00299
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071572
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 12/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2017
Device Catalogue NumberCX-XRY39501
Device Lot Number160602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2016
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: 12/21/2016 Patient Sequence Number: 1
Treatment
ALBUMIN; CV-510H1 LOT# 160808; CX-XPU39501 LOT# 160810; HEPARIN 5CC; SOLULACT
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