MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR

Catalog Number CX-XRX59602

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device has been received by the manufacturing facility for evaluation.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.A review of the device history record and the product release decision control sheet of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a clot during the use of a capiox device.Follow up communication with the user facility confirmed the following information: during a bentall case, after a pause of the circulation for 33 minutes, when the circulation was resumed, clots were noted around 400ml of the reservoir level; it was a usual extracorporeal circulation with act higher than 400 seconds; and it was reported that the patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the returned sample evaluation results.The actual device has been received by the manufacturing facility for evaluation.Visual inspection of the actual device revealed no anomalies or defects.The actual device was subjected to another visual inspection after rinsed.The venous and cardiotomy filters were confirmed to be in the normal state.The pressure drops were then determined at the cardiotomy and venous filters by circulating bovine blood in the actual sample.The results did not show any anomaly which could be a trigger of the formation of clots and the determined values met manufacturer specifications.Bovine blood was then circulated in the actual sample for six hours and revealed no clot formation.The actual sample was rinsed and the venous filter was removed for further inspection.Visual and electron microscopic inspections of the venous filter revealed no anomalies or defects.The defoamer set inside the venous filter was then taken out of the filter for visual and electron microscopic inspections and revealed no defects.Visual and electron microscopic inspections of the cardiotomy filter revealed no defects.The defoamer set inside the cardiotomy filter was then taken out of the filter for visual and electron microscopic inspections and revealed no defects.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the actual sample was the normal product.An exact cause of the reported event cannot be definitively determined.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "adequate heparinization of the blood is required to prevent it from clotting in the system.Do not reduce heparin during circulation.Otherwise, blood clotting might occur." 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
• Type of Device: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6088858
• MDR Text Key: 59466107
• Report Number: 9681834-2016-00249
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: CX-XRX59602
• Device Lot Number: 160901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1