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

Catalog Number	CX*RX05RW
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has 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 records and product release decision control sheet of the involved product code/lot # combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# 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 difficult in disconnecting the oxygenator from the manifold.The following information was provided by the user facility: the pressure line that goes from the oxygenator to the manifold would not disconnect, connection was bonded closed; the event happened during set up of the machine; the device was changed out; this did not cause a delay in the procedure; the procedure was completed successfully; and there was no patient involvement with the reported device.
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 found the connecter for the sampling line had the marks on it, implying it had been pinched with forceps.No other anomalies were noted on the remainder of the device.An attempt to release the luer fitting of the connector was made.The male component was detached from the female component by hand with no difficulty.The taper of the connector (angles and dimensions of the components to be fitted with each other) was checked with the lure taper gauge and confirmed to meet iso standard (6/100 tapered).It was found to be compatible with the lure taper gauge.There is no evidence that this event was related to a device defect or malfunction.During the actual sample evaluation the lure fitting of the male and female components of the connector of the actual sample was able to be released manually without any difficulty.The customer's complaint was not confirmed.The exact cause of the reported event cannot be definitively determined based on the available information.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: 6589695
• Report Number: 9681834-2017-00100
• Device Sequence Number: 978520
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: (01)04987350763471(17)190228(10)160328
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K022115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 02/28/2019
• Device Catalogue Number: CX*RX05RW
• Device Lot Number: 160328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 06/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1