MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX15; OXYGENATOR

Catalog Number	CX*RX15RW30
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing facility for evaluation.Visual inspection found no anomalies which would relate to a gas leak or insufficient gas transfer performance.The actual sample, after having been rinsed and dried, was tested for its gas transfer performance in accordance to the factory's shipping inspection protocol.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory specifications.A review of the device history record and product release decision control sheets of the involved product/lot# combination was conducted with no relevant findings.A search of the complaint file found no report with the involved product code/lot# combination.The investigation result verified that the actual sample, after having been rinsed and dried, was the normal product with no issue in the gas transfer performance.Based upon the available information, the cause for the reported event cannot be definitively determined.There are many complex clinical variables that may have affected the reportedly observed conditions during the procedure.However, there is no indication that the reported event was related to a product malfunction or defect.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as: "a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improme the performance.Increase gas flow rate, to 15 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved." 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 insufficient gas exchange in the capiox device.Follow up communication with the user facility confirmed the following information: four and a half hours into the procedure the oxygenator device started to fail; po2 10-12kpa at 100% fio2; the patient, still cooled, finished the procedure, rewarmed and came off bypass; the oxygenator was then swapped out in case they needed to go back to bypass; the initial procedure was to close a hole in the heart but went on to involve a valve procedure as well; the patient had a previous biliary atresia surgery and abnormal liver protein profile; blood loss was reported but the amount of blood loss is unknown; and the procedure was completed successfully.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 for mfg.Report no.9681834-2016-00068 to correct the information that was initially reported.The brand name was initially reported as capiox rf15, the correct brand name is capiox rx15.
Event or Problem Description
This report is being submitted as follow-up no.1 for mfg.Report no.9681834-2016-00068 to correct the information that was initially reported.The brand name was initially reported as capiox rf15, the correct brand name is capiox rx15.

• Brand Name: CAPIOX RX15
• Common Device Name: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5545440
• Report Number: 9681834-2016-00068
• Device Sequence Number: 19037797
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2016
• Supplement Report FDA Received Date: 04/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 20