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

Catalog Number	CX*FX25E
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not 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, evaluation code 20 has been referenced in the conclusions section of h6.A review of the device history records and 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.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 at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported the inlet connector melted on the capiox device during setup.The following information was provided by the user facility: the product was changed out; the surgery was completed successfully; and there was no patient involvement.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.The actual device was not returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of user facility information and retention sample of the involved product code/lot number combination.Visual inspection revealed no anomalies or defects.The cap that is applied to the blood inlet port was removed to further inspect the blood inlet port.Visual inspection revealed no defects.The investigation results verified that the actual sample was the normal product.There is no evidence that this event was related to a device defect or malfunction and the exact cause for the reported event cannot be definitively determined.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6427895
• Report Number: 9681834-2017-00062
• Device Sequence Number: 10913255
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: (01)04987350701060(17)20191031(10)161110
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Initial,Followup
• Report Date (Section B): 03/23/2017

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: 10/31/2019
• Device Catalogue Number: CX*FX25E
• Device Lot Number: 161110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1