MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX OXYGENATOR

Catalog Number	CX*RX25RE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned to the manufacturing facility for evaluation.Visual inspection found the sampling line tube had been almost fractured at the joint with the venous blood inlet port on the reservoir lid.There were no other anomalies noted.Magnifying and electron microscopic inspections of the fracture cross-sections of the tube found that some segments were in the smooth state and others in the rough state with the generation of some streaks on them.There were no embedded foreign particle or entrainment of air bubbles which would have contributed to the generation of the fracture.The sampling line tube was cut vertically and subjected to dimensional checks.Both the outside and inside diameters met manufacturing specification.Simulation testing was conducted.The sampling line tube of a current product sample was exposed to an instantaneous shock force at the joint of the sampling line tube and the venous blood inlet port on the reservoir lid after the sample had been left under a low temperature for 12 hours.The sampling line tube became fractured at the joint.Electron microscopic inspection of the fracture cross-section found that the state of the surface was very similar to that of the actual sample.A review of the device history record and the product release decision control sheet of the product code/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.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the available information, it is likely that the actual device was subjected to a shock force.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: (1) "do not use if the package and/or device is damaged (e.G.Cracked) or any of the port caps are off.(2) "do not use an oxygenator that leaks." 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 leakage in the capiox device.Follow up communication with the user facility confirmed the following information: during priming, the perfusionist saw a leak from the venous reservoir, mainly at the entrance; the oxygenator was changed; and there was no patient involvement.

• Brand Name: CAPIOX RX OXYGENATOR
• Common Device Name: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6122447
• Report Number: 9681834-2016-00257
• Device Sequence Number: 19114951
• Product Code: DTZ
• UDI-Device Identifier: 04987350769558
• UDI-Public: 04987350769558
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/22/2016

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: 10/31/2018
• Device Catalogue Number: CX*RX25RE
• Device Lot Number: 151130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1