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

Catalog Number	CX*FX15RW30
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing facility for evaluation.Visual inspection of the actual sample revealed no anomalies in its appearance.The actual sample, after having been rinsed and dried, was subjected to another visual inspection.No anomalies were noted.The actual sample was built into a circuit with tubes and bovine blood circulated in it and the pressure drop was determined at each flow rate.The obtained values were verified to meet manufacturing specifications.There were no anomalies which could cause an increase in the pressure in the actual sample.The bovine blood was circulated in the sample for 6 hours.There was no generation of occlusion which could cause an increase in the pressure in the actual sample.Visual inspection of the sample after the blood had been removed from it confirmed that there was no clot formation either in the oxygenator module or in the venous reservoir.A review of the device history record 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.The investigation result verified that the actual sample, after having been rinsed and dried, was the normal product with no issues.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.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: after starting the hlm (ekz) and an act 620 seconds in normothermia, continuous delta-p increase to 680mm/hg within minutes; the patient was removed from hlm; the system was changed out to a sorin evolution; there was no increase of delta-p; the surgery was completed; the amount of blood loss was unknown; and the patient was reported as doing good.

• Brand Name: CAPIOX FX OXYGENATOR
• Common Device Name: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5612372
• Report Number: 9681834-2016-00104
• Device Sequence Number: 16279391
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: 04987350701169
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071494
• 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): 04/27/2016

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: 10/31/2018
• Device Catalogue Number: CX*FX15RW30
• Device Lot Number: 151117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2016
• Initial Report FDA Received Date: 04/27/2016
• 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: SORIN EVOLUTION; SORIN EVOLUTION
• Outcome Attributed to Adverse Event: Other