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

Catalog Number	CX*RX25RE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/30/2017
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 fractured off at the joint with the blood inlet port on the reservoir.No other damage was noted on the rest of the device.Magnifying and electron microscopic inspections of the fracture cross-sections of the sampling line tube did not reveal any embedded foreign particle or entrainment of air bubbles which would have contributed to the generation of the fracture.It was revealed that some segments were in the smooth state and other segments in the rough state.On the smooth surface some streaks were found to have been generated, starting at one point.This implies that the fracture developed, starting at this point, in the direction of the streaks.Simulation testing was conducted.The state of the fracture of the sampling line tube of the actual device is experientially known to be consistent with the state when the tube was fractured as a result of been exposed to a shock force under a cold temperature.The sampling line tube of a current product sample was exposed to a shock force at the joint of the tube and the reservoir inlet port after it having been left under a low temperature of 4°c for 12 hours.The sampling line tube became fractured at the joint.Electron microscopic inspection of the fracture cross-section found the state of the surface was very similar to the actual device.A review of the device history record and product release decision control sheet from the reported 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/lo number combination.There is no evidence this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the actual device was cooled by having been left under a low temperature during transportation, and in the cooled state, it was subjected to a shock force and became fractured.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.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 prior to a procedure.Follow up communication with the user facility confirmed the following information: upon priming the device the perfusionist noticed a leak of volume from the recirculation line of the manifold to near the venous return inlet; the prime line was reported to have been broken; the perfusionist changed the reservoir and oxygenator; and there was no patient involvement.

• Brand Name: CAPIOX RX 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: 6896803
• Report Number: 9681834-2017-00204
• Device Sequence Number: 13618509
• Product Code: DTZ
• UDI-Device Identifier: 04987350769558
• UDI-Public: (01)04987350769558(17)191130(10)161220
• 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): 09/27/2017

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: 11/30/2019
• Device Catalogue Number: CX*RX25RE
• Device Lot Number: 161220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1