MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*FX05RE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/11/2017
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 record and shipping inspection record of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot number 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 a leak in the capiox device during priming.Follow up communication with the user facility provided the following information: (1) a leak of priming solution was noted at the arterial blood exit of the oxygenator; (2) after inspection, a crack was found in the arterial blood exit; (3) the oxygenator was taken from the box, there were no signs of damage on the oxygenator box; and (4) there was no patient involvement.
Additional Manufacturer Narrative
This report is being submitted as follow up number 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 complaint.The actual sample had a crack on the blood outlet port.There was not any other anomalies on the other parts of the device.The actual sample was built into a circuit with tubes.Colored saline solution was circulated in the circuit.A leak was noted at the crack on the blood outlet port.Simulated testing was conducted using current product samples, but could not be duplicated.There is no evidence that this event was related to a device defect or malfunction.While the actual cause of the reported event cannot be definitively determined based on the available information, it is likely that the actual sample was exposed to a shock force which exceeded the strength limit of this product and became cracked on the blood outlet port.Ashitaka factory conducts 100% leak test and 100% visual inspection on this product before application of the caps to the ports.It is likely that the actual sample became damaged after the sample left the manufacturing facility.However, it cannot be determined when and how the device became damaged.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir." 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 FX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6552426
• Report Number: 9681834-2017-00092
• Device Sequence Number: 11007632
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: (01)04987350781758(17)190531(10)160622
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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: 05/31/2019
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 160622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1