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

Catalog Number	1CX*FX25E
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi - the lot number is unknown for the product code reprorted, however the di portion was provided.The actual device has not been returned to the manufacturing facility for 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.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.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 high resistance on the capiox device post cardiopulmonary bypass.Follow up communication with the user facility reported the following information: no known impact to the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to 1) provide the returned sample evaluation; 2) provide the device return date in section d10; 3) provide the lot number & expiration date in section d4; 4) provide the manufacturer date in section h4.The actual device was returned to the manufacturing facility for evaluation.Visual inspection revealed no defects.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 was found.Bovine blood was circulated in the circuit for 6 hours.No obstruction was observed.The actual sample was then rinsed out.Subsequent visual inspection confirmed no clot formation.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.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "(1) do not reduce heparin during circulation.Otherwise, blood clotting might occur.(2) adequate heparinization of the blood is required to prevent it from clotting in the system." 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 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: 6310319
• Report Number: 9681834-2017-00004
• Device Sequence Number: 16329733
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: 04987350701060
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 02/08/2017

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: 07/31/2019
• Device Catalogue Number: 1CX*FX25E
• Device Lot Number: 160811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1