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

Catalog Number	CX*RX15RE30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2017
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.For this reason code 20 was used in the conclusions section of h6.A review of the device history record and product release decision control sheet 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 damage to the capiox device prior to priming.Follow up communication from the user facility reported the following information: the venous entrance to oxygenator was noted to have been broken; the event occurred during cec assembling, prior to priming; the oxygenator was changed out to another capiox rx15re30 device; and there was no patient involvement.
Additional Manufacturer Narrative
This report is being submitted as follow up number 1 to provide the returned sample investigation results.The actual sample was returned to the manufacturing facility for evaluation.Visual inspection found the blue cap, which should have been attached to the blood inlet port, had come off.Closer visual inspection of the device found that the blood inlet port had a black ring mark around it where the blood inlet port had been dented.The blue cap which was found in the individual pack was inspected under magnification.Generation of some scratches were noted both on the external and internal surfaces.The actual sample was set in its original cushion materials in the original manner where the blood inlet port was sandwiched with them and the locational relationship between the blood inlet port and the cushion materials was checked.It was found that the blood inlet port did not come into contact with any cushion materials when the device was packed in the box.Simulation testing was conducted.The blue capped blood inlet port of a current product sample was subjected to a pushing force by pushing the capped port against a desk with the cap facing to the flat plate of the desk.A dent was generated on the blood inlet port in the inward direction with the generation of some scratches both on the external and internal surfaces of the blue cap.There is no evidence that 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 sample was unpacked from its package, the blood inlet port with the blue cap attached was exposed to an external force and deformed into the dented shape resulting in the reported event.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "inspect the device and package carefully.Do not use if the package and/or device is damaged." 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 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: 6485686
• Report Number: 9681834-2017-00072
• Device Sequence Number: 10975428
• Product Code: DTZ
• UDI-Device Identifier: 04987350771032
• UDI-Public: (01)04987350771032(17)190630(10)160709
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: 06/30/2019
• Device Catalogue Number: CX*RX15RE30
• Device Lot Number: 160709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1