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

Catalog Number	1CX*FX25E
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/08/2016
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 a kink on the purge line.Follow up communication with the user facility confirmed the following information: the purge line had been squeezed together; the procedure 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 returned sample evaluation results.The actual device was returned to the manufacturer for evaluation.Visual inspection upon receipt found that the purge line tube had been partially crushed.There were no other anomalies on the remainder of the device.Magnifying inspection of the crushed segment revealed that some streaks had been generated in parallel with one another.The interval of the streaks was found to be very similar to that between the grooves created on the edge of the housing on the water port side.The cushion materials, including the corrugated card board, used to pack this product were inspected for their shapes.Their shapes were found not to match the impression of the crush generated on the purge line tube.Based on the investigation result, it is likely that the purge line tube of the actual sample was in the state of being sandwiched between the oxygenator module and the sterile pack, resulting in the generation of the damage.From the available information, however, it cannot be determined when and how the purge line tube was damaged.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "do not use if the package and/or device is damaged, or if caps are not in place." 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: 6001370
• Report Number: 9681834-2016-00244
• Device Sequence Number: 10972741
• 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): 10/05/2016

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: 160511
• 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: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• 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