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

Catalog Number	CX*FX15RW30
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing facility and the investigation is currently ongoing.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 records and the product release decision control sheet of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no 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 at the manufacturing facility for appropriate tracking, trending and follow-up.H3 other text : device is currently under evaluation.
Event or Problem Description
The user facility reported a pressure increase when using the capiox device.Follow up communication with the user facility confirmed the following information: perfusion started at 10:36 with a delta p about 120mmhg; pressure continuously increased up to 420mmhg at 11:00; it was reported that the complete machine was exchanged; the procedure was completed successfully; and it was reported that there was no harm to the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up # 1 to provide the returned sample evaluation results.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no obvious anomalies.The actual sample, after having been rinsed and dried, was subjected to another visual inspection.No anomalies were revealed.The actual sample was built into a circuit with tubes and bovine blood was circulated through it.The pressure drop was determined at each flow rate.The obtained values were verified to meet manufacturing specification.The bovine blood was circulated in the sample for 6 hours.There was no generation of obstruction.Saline solution flowed through the circuit to remove the blood.Subsequent visual inspection of the actual sample confirmed that there were no formation of clotting.Review of the provided pump record noted that at 11:00, the blood flow rate and cystic temperature was noted to have decreased.There is no evidence that this event was related to a device defect or malfunction.The evaluation result verified that the actual sample, after having been rinsed and dried, was the normal product with no occlusion related issue.Although the exact cause of the reported event cannot be definitively determined based on the available information, it is likely that the pressure became decreased gradually while the patient was being cooled down.From this it is assumable that cold agglutination occurred, resulting in an obstruction in the oxygenator module.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "do not reduce heparin during circulation.Otherwise, blood clotting might occur.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 FX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5971387
• Report Number: 9681834-2016-00228
• Device Sequence Number: 441262
• 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,Followup
• Report Date (Section B): 09/22/2016

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: 03/31/2019
• Device Catalogue Number: CX*FX15RW30
• Device Lot Number: 160425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2016
• Supplement Report FDA Received Date: 10/03/2016
• 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 Age: 74 YR
• Patient Weight: 63