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)
Date of Event	12/28/2015
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.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and product release decision control sheets.A review of complaint files confirmed that there were no similar reports in the past three years.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 leakage in the capiox fx15 device.Follow up communication with the user facility confirmed the following information: (1) the heater cooler outlet connection on the oxygenator was damaged and leaking during setup; (2) the oxygenator was changed out during setup; (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 mfg.Report no.9681834-2016-00001 to provide the return sample evaluation results and to provide updated information.The lot number was initially reported as unknown.The lot number was determined to be 150608 and the expiration date is 05/31/2018.The report will be updated with the manufacturing date: 06/08/2015.The actual device was returned to the manufacturer for evaluation.Visual inspection upon receipt confirmed the reported complaint.The water out port was noted to have damage.Closer inspection of the configuration of the deformity on the water out port found that the distal edge of the port had been dented inward.A tube was connected to the water out port in the manner where the joint would not be affected by the deformity on the port.The actual sample was then pressurized for six hours.No leak was confirmed.Simulation testing was conducted.The water out port on a current product sample was exposed to an external shock force and damaged in a state similar to that on the actual complaint sample.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.There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined.Based on the investigation results, it is likely that a gap was generated between the water out port and a coupler or a tube connected to the deformed water out port, resulting in a leak during the actual use.As a cause of the water out port of the actual sample being deformed, it is likely that the actual sample was exposed to a shock force on the water out port during shipping, storage or after having been unpacked.
Event or Problem Description
This report is being submitted as follow-up no.1 for mfg.Report no.9681834-2016-00001 to provide the return sample evaluation results and to provide updated information the lot number was initially reported as unknown.The lot number was determined to be 150608 and the expiration date is 05/31/2018.The report will be updated with the manufacturing date: 06/08/2015.The user facility reported a similar event for another device with the same product code and lot number, see mdr 9681834-2016-00003.

• 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: 5392495
• Report Number: 9681834-2016-00001
• Device Sequence Number: 18870136
• 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
• Report Date (Section B): 01/27/2016

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: 05/31/2018
• Device Catalogue Number: 1CX*FX15E
• Device Lot Number: 150608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2016
• Supplement Report FDA Received Date: 02/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1