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

Catalog Number	CX*RX15RE30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned to the manufacturing facility for evaluation.Visual inspection found that the unit box and cushion materials inside had been damaged.The actual sample was taken out of the package for closer inspection.It was found that the three female ports on the sampling system had been fractured off and the yellow caps attached to them had been broken into pieces.The position of the sampling system on the actual sample was found to have been packaged in the opposite direction compared to that of a retention sample of the involved product code/lot#.Inspection of the sterile bag the device was packaged in was found to have three contact traces at the positions that almost match where the three yellow caps and female ports come into contact with the bag when the product is packed.Magnifying and electron microscopic inspections of the fracture cross-sections on the sampling system and on the fractured female ports revealed that all of them had rough part and smooth part on their surfaces, with the generation of some streaks which started to spread downward from the upper side on the smooth part.The locational relationship between the cushion material and the female ports on the sampling system was checked and found that the female ports were located on the space of the cushion material where they would not be subjected to any direct force.Simulation testing was conducted.The female ports on the sampling system of the retention sample were exposed to a shock force applied respectively from the front and from the upper lateral side.One of the female ports became fractured off when they were exposed to a shock force applied from the upper lateral side.Magnifying and electron microscopic inspections of the fracture cross-sections of the female port revealed that the state of their surfaces were very similar to those 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, such as a dropping force, during transportation or during unpacking.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 if the package and/or device is damaged (e.G.Cracked) or any of the port caps are off." (b)(4).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 damage to the capiox device.Follow up communication with the user facility confirmed the following information: upon opening the box it was reported that the three-way keys were broken; 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: 6113889
• Report Number: 9681834-2016-00255
• Device Sequence Number: 974300
• Product Code: DTZ
• UDI-Device Identifier: 04987350771032
• UDI-Public: 04987350771032
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K051997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2016

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*RX15RE30
• Device Lot Number: 151111
• 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: 10/21/2016
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1