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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 ZZ*FX25RWA
Device Problems Occlusion Within Device (1423); Filtration Problem (2941)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2017
Event Type  malfunction  
Manufacturer Narrative
This report is being submitted as follow up number 1 to provide the evaluation results of the actual device used in this event. The actual device was returned to the manufacturing facility for evaluation. Visual inspection found no obvious anomalies in its appearance. The actual sample, after having been rinsed and dried was built into a circuit with tubes and bovine blood was circulated in it and the pressure drop was determined at each flow rate. The obtained values were verified to meet manufacturing specifications. The bovine blood was circulated in the sample for 6 hours. There was no pressure drop which could imply the possibility of clot formation. After the bovine blood circulation, water was flushed through the circuit. No clot formation was confirmed. A review of the device history record 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. There is no evidence this event was related to a device defect or malfunction. The investigation result verified the actual sample was the normal product without any pressure drop which could lead to a clot formation issue. The exact cause of the reported event cannot be definitively determined based on the available information. 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. All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
 
Manufacturer Narrative
(b)(4). The actual device has been returned to the manufacturing facility for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. For this reason (b)(4) was used in the conclusions section of evaluation codes. (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 clotting in the capiox device during a procedure. Follow up communication with the user facility confirmed the following information: a clot was noticed on the oxygenator at the end of the case; the problem occurred after cardiopulmonary bypass; and the procedure was successfully completed.
 
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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 Key6856522
MDR Text Key255416834
Report Number9681834-2017-00182
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Catalogue NumberZZ*FX25RWA
Device Lot Number161223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2016
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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