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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-XRX55801
Device Problem Occlusion Within Device (1423)
Patient Problem Blood Loss (2597)
Event Date 08/26/2016
Event Type  Injury  
Manufacturer Narrative
The actual device was discarded by the involved facility. Therefore, the investigation was based on the evaluation of the user facility information and a retention sample from the same manufacturing date as the reported device. Visual inspection revealed no anomalies in the appearance. Bovine blood was circulated in the sample, while the pressure loss at the cr filter housed inside the reservoir was determined. The obtained values were confirmed to meet manufacturing specifications. No anomalies which could lead to clot formation were noted. Bovine blood was circulated in the sample for 6 hours. During this circulation, no obstruction occurred in the circulation and there were no visible clot formation found inside. The cr filter was disassembled and rinsed with saline solution. Subsequent visual inspection of the cr filter and defoamer set inside the cr filter found no clot formation on those components. The cr filter and defoamer were rinsed with hypochlorous acid solution so as to remove the blood cell components adhering on them. Subsequent electron microscopic inspection of those components did not reveal any anomalies which could lead blood to clot. A review of the device history record and the product release decision control sheet of the involved product code/lot # 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. The investigation result verified that the retention sample had no anomalies which could lead to the reported clotting. Although the exact cause of the reported event cannot be definitively determined based on the available information, many clinical variables could have lead to the reported issue. The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: "do not reduce heparin during circulation. Otherwise, blood clotting might occur. Adequate heparinization of the blood is required to prevent it from clotting in the system. " (b)(4). All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up. Actual device was discarded.
 
Event Description
The user facility reported formation of clots during the use of the capiox device. Follow up communication with the user facility confirmed the following information: the customer noticed that clots had formed on the cr filter housed in the hard shell reservoir; to prevent the clots from flowing into the oxygenator module side, the customer changed out the reservoir and oxygenator module to new ones; the amount of bloodloss is unknown; the procedure was completed successfully; 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 Key5971345
MDR Text Key55422640
Report Number9681834-2016-00226
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 09/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Catalogue NumberCX-XRX55801
Device Lot Number160524
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2016
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: 09/22/2016 Patient Sequence Number: 1
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