MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	1CX*FX25W
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: udi - not required for the reported product code/lot number combination, however the di portion was provided.The actual device was returned to the manufacturing facility for evaluation.Visual inspection revealed no defects.Blood was found to have been infiltrated in the inside fibers located on the gas-out side, likely due to the disposable circuit being put into a bag with blood in it.The actual sample was rinsed and dried and then subjected to another visual inspection and revealed no defects.The actual sample was built into a circuit with tubes.Bovine blood was circulated in the circuit and the pressure drop was determined at each flow rate.The obtained values were confirmed to meet manufacturer specifications and no obstruction that could lead to an increase in the pressure was found.Bovine blood was circulated in the circuit for 6 hours.No obstruction was observed that could lead to an increase in the pressure.The actual sample was then rinsed out.Subsequent visual inspection confirmed no clot formation.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.The investigation results verified that the actual sample was the normal product.There is no evidence that this event was related to a device defect or malfunction and the exact cause for the reported event cannot be definitively determined.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 blood flow on the capiox device during cardiopulmonary bypass.The following information was provided by the user facility: there was a forward flow of a circuit issue; the perfusionist initiated hand cranking, then changed out circuit; there was a delay in the procedure by approximately two minutes; blood loss was reported to be over 200 ml; the procedure was completed successfully.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6325331
• Report Number: 9681834-2017-00018
• Device Sequence Number: 577739
• Product Code: DTZ
• UDI-Device Identifier: 04987350701084
• UDI-Public: 04987350701084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071494
• 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
• Report Date (Section B): 02/13/2017

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: 06/30/2019
• Device Catalogue Number: 1CX*FX25W
• Device Lot Number: 160714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 02/13/2017
• 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