MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX15 W/ 3L RESERVIOR (LT. PORT); OXYGENATOR

Catalog Number	CX*RX15RW30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	01/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.- patient code = 2597 - although there was reportedly no impact to the patient, the event description indicates blood loss did occur.The amount of blood loss was unknown.The actual device was received by the manufacturing facility and is currently under evaluation.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.For this reason code 11 was used in the conclusions section of h6.A review of the device history record and the product release decision control sheet of the involved product/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.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 for appropriate tracking, trending and follow-up.H3 other text : currently under evaluation.
Event or Problem Description
The user facility reported a leak in the capiox rx15 device.Follow up communication with the user facility confirmed the following information: it was reported on (b)(6) 2016, the leak was detected during priming.There were no complications for patient.The oxygenator was changed out and procedure continued.It was reported there was some blood loss but not significant.It was reported there was a delay in surgery.The procedure was completed successfully.It was reported the patient was not harmed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 for mfg.Report no.9681834-2016-00015 to provide the results of the returned device evaluation.The actual device and a photo showing the actual sample during use were returned to the manufacturing facility for evaluation.The photo of the blood inlet port of the actual sample was noted to have been connected with a 1/4 adapter and blood leak was noted at the joint of these two components.The involved adapter was not returned.Visual inspection of the actual sample upon receipt revealed no defects.Magnifying inspection of the blood inlet port revealed no defects.The outside diameter of the blood inlet port was confirmed to meet manufacturer specifications.The factory-retained adapter was connected to the blood inlet port of the actual sample and was further tightened.Subsequently, saline solution was circulated in the actual sample from the blood inlet port at the flow rate of 3.0l/min.For 6 hours.No leak occurred.Functional testing was conducted and was able to reproduce the reported defect.The factory-retained adapter was connected to the blood inlet port of the actual sample with insufficient tightening.Saline solution was circulated in the actual sample at the flow rate of 3.0l/min.A leak was noted at the joint of the two components.With a torsional force applied to the tube connected to the adapter, the adapter was connected to the blood inlet port of the actual sample and tightened to the level the prime did not leak.Then, saline solution was circulated in the actual sample at the flow rate of 3.0l/min.A leak was noted at the joint of the two components 5 minutes after the circulation was started.The leakage was observed to be similar to that of the actual sample.There is no evidence that this event was related to a device defect or malfunction.With no return of the involved adapter the exact cause cannot be determined.Based on the investigation it is likely that: the adapter was not tightened to the blood inlet port of the actual sample sufficiently.During the set-up or priming, the tube connected to the adapter was given some torsional force.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.
Event or Problem Description
This report is being submitted as follow up no.1 for mfg.Report no.9681834-2016-00015 to provide the results of the returned device evaluation.

• Brand Name: CAPIOX RX15 W/ 3L RESERVIOR (LT. PORT)
• Common Device Name: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5444127
• Report Number: 9681834-2016-00015
• Device Sequence Number: 325729
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 02/18/2016

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: 07/31/2017
• Device Catalogue Number: CX*RX15RW30
• Device Lot Number: 140807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2016
• Supplement Report FDA Received Date: 03/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXYGENATOR CHANGED OUT FOR A SORIN