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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF

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TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF Back to Search Results
Catalog Number 1CX*FX25E
Device Problem Failure to Prime (1492)
Patient Problem No Patient Involvement (2645)
Event Date 01/12/2017
Event Type  malfunction  
Manufacturer Narrative
Udi - the udi is not required for the reported product code/lot number combination, however the di portion was provided. The actual device has not been returned to the manufacturing facility for evaluation. For this reason, (b)(4) was used in the conclusions section. A follow up report will be submitted within 30 days of this report being sent. A review of the device history record and the product release decision control sheet of the involved product/lot # combination was conducted with no relevant findings. A search of the complaint file did not find any other report with the involved product code/lot# combination. (b)(4). All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.
 
Event Description
The user facility reported that the capiox device failed to prime during setup. Follow up communication with the user facility confirmed the following information; the locked volume out of the bottom vent would not prime; it would prime during normosol; the product was changed out; the procedure was completed successfully; and there was no patient involvement.
 
Manufacturer Narrative
This report is being submitted as follow up no. 1 to provide additional information about the device return in device available for evaluation?. The actual device is not available for evaluation. A follow up report will be submitted once the investigation is complete. For this reason, (b)(4) is referenced.
 
Manufacturer Narrative
This report is being submitted as follow up no. 2 to provide the retention sample evaluation results, provide the entire udi no. & the expiration date. The actual device was not returned to the manufacturing facility. Therefore, the investigation was based upon evaluation of user facility information and a retention sample of the involved product code/lot number combination. Visual inspection of the retention sample revealed no defects. Functional testing was conducted and could not duplicate the reported event. The investigation verified that the retention sample was the normal product. During the inspection, the reported event was not duplicated. With the absence of the actual sample to be evaluated, the cause of this complaint cannot be determined. All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
 
Manufacturer Narrative
This report is being submitted as follow up number 3 to provide the returned sample evaluation results. The actual device was returned to the manufacturing facility for evaluation. Visual inspection found no anomalies. The actual sample was filled with saline solution. With the blood outlet port clamped and pressure applied to the blood pathway from the blood inlet port side for 6 hours. No leak was confirmed. The water pathway of the heat exchanger module was filled with water. With the water outlet port clamped pressure was applied to the water pathway of the heat exchanger module from the water inlet port side for 6 hours. No leak was confirmed. The actual sample was built into a circuit with tubes. Saline solution colored for better visibility was let to flow into the circuit little by little. As a result, the reported complaint could not be duplicated. There is no evidence that this event was related to a device defect or malfunction. The actual sample was confirmed to be normal product. The exact cause of the reported event cannot be definitively determined based on the available information. All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
 
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Brand NameCAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
Type of DeviceOXYGENATOR
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 Key6310339
MDR Text Key66777531
Report Number9681834-2017-00007
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,Followup,Followup
Report Date 02/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number1CX*FX25E
Device Lot Number160721
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2016
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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