MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF

Catalog Number	1CX*FX15E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not been returned to the manufacturing facility for evaluation.A follow up report will be submitted within 30 days of this report being sent.For this reason, evaluation code 11 was used in the conclusions section of h6.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 of this nature with the involved product code/lot# combination.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.H3 other text : device not returned to manufacturer.
Event or Problem Description
The user facility reported a leak in the capiox fx15 device.Follow up communication with the user facility confirmed the following information: (1) leaking occurred near the seal on the heat exchanger; (2) the product was changed out; (2) surgery was completed successfully; and (3) there was no patient involvement.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 for mfr.Report no.9681834-2015-00266 to provide an update on the status of this report.As of february 26, 2016 the device has not been received by the manufacturer for evaluation.The investigation is yet to be completed.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.
Event or Problem Description
This report is being submitted as follow up no.1 for mfr.Report no.9681834-2016-00003 to provide an update on the status of this report.
Additional Manufacturer Narrative
As stated, this report is being submitted as follow-up # 2 for mfg.Report # 9681834-2016-00003 to notify the fda the initial report submitted on 01/29/2016 and the follow up # 1 submitted on 02/26/2016 is a duplicate report for mdr no.9681834-2016-00001.
Event or Problem Description
This report is being submitted as follow-up # 2 for mfg.Report # 9681834-2016-00003 to notify the fda the initial report submitted on 01/29/2016 and the follow up # 1 submitted on 02/26/2016 is a duplicate report for mdr no.9681834-2016-00001.

• Brand Name: CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF
• Common Device Name: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5399949
• Report Number: 9681834-2016-00003
• Device Sequence Number: 843732
• Product Code: DTZ
• UDI-Device Identifier: 04987350701183
• UDI-Public: 04987350701183
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date (Section B): 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 1CX*FX15E
• Device Lot Number: 150608
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/29/2016
• Supplement Report FDA Received Date: 02/26/2016; 03/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1