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

Catalog Number	1CX*FX25E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/27/2016
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 when the investigation is complete, but no later than 30 days from the date that this report was sent.For this reason code 11 was used in the conclusions section of h6.A review of the device history record and product release decision control sheets of the involved product/lot# combination was conducted with no relevant findings.A search of the complaint file found no 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.H3 other text : device not returned to manufacturer.
Event or Problem Description
The user facility reported a leak in the fx25 capiox device.Follow up communication with the user facility confirmed the following information: a pinhole leak occurred at the manifold during prime.The product was changed out.The surgery was completed successfully.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 manufacturing facility for evaluation.Visual inspection upon receipt found the sampling line tube had a crack on the segment adjacent to the female connector.Water was let to flow through the actual sample by gravity.A leak was revealed at the crack.The female connector was inspected under magnification and found to have a crack.The surface of the crack on the tube was found to be in the smooth state.Ct-scanning of the female connector revealed that the segment of the tube inserted in the female connector also had a crack.Functional testing was conducted: a test sample of which a female connector on the sampling line had a tube attached to it was prepared.A shock force was applied to the female connector.Consequently, cracks were observed to be similar to those on the actual sample.Ct-scanning of the female connector revealed that the segment of the tube inserted in the female connector also had a crack.Damage on the female connector and tube of the test sample was observed to be similar to that on the actual sample.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 actual sample was subjected to a shock force.The device labeling does address the potential for such an event in the instructions-for-use (ifu): "do not use if the package or device is damaged (e.G.Cracked) or any of the part caps are off.Do not use an oxygenator that leaks." all available information has been placed on file in quality assurance 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: 5880152
• Report Number: 9681834-2016-00204
• Device Sequence Number: 19005955
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: 04987350701060
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2016

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: 02/28/2019
• Device Catalogue Number: 1CX*FX25E
• Device Lot Number: 160317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2016
• Supplement Report FDA Received Date: 09/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1