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

Catalog Number	1CX*FX25E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not been returned to the manufacturing facility for evaluation.For this reason, evaluation code 11 was used in the conclusions section of h6.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.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.
Event or Problem Description
The user facility reported the temperature probe was found broken during setup.Follow up communication with the user facility confirmed the following information: 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 # 1 to provide the returned sample evaluation results.The actual device was returned to the manufacturing facility for evaluation.Visual inspection confirmed the customer's observation.The thermistor probe on the oxygenator outlet port had been broken off.There were no other anomalies or defects on the remainder of the device.Magnifying inspection of the fracture cross-sections of the thermistor probe found no anomalies or defects which could have deteriorated the strength.Electron microscopic inspection of the fracture cross-sections revealed some smooth segments and a rough segment on the surface, with the generation of some streaks starting on the smooth surface and spread out to the rough segments.Simulation testing was conducted on a test sample.The test sample was exposed to a shock force on the thermistor probe.The thermistor probe broke off.Subsequent electron microscopic inspection of the fracture cross-section found that the segment on the side where the shock force had been applied was in the smooth state and that the opposite side was in the rough state with the generation of some streaks starting on the smooth surface going toward the rough surface.There was no generation of a deformity or dent on the surface of the thermistor probe.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be definitively determined based on the investigation results, it is likely the thermistor probe of the actual sample was subjected to a shock force.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: (1) "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX FX25 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: 6011689
• Report Number: 9681834-2016-00237
• Device Sequence Number: 10937126
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: 04987350701060
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/07/2016

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: 04/30/2019
• Device Catalogue Number: 1CX*FX25E
• Device Lot Number: 160520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2016
• Supplement Report FDA Received Date: 11/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1