MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15; OXYGENATOR

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

The involved device has not been returned to the user facility for evaluation and the production lot number is unknown.Therefore, a meaningful evaluation of retention samples, device history records and complaint files could not be conducted.The complaint files related to all fx15 products confirmed that there were no similar reports of this nature in the past three years.(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

This report is being submitted in response to maude event report # mw5059640 that was found during a maude search on (b)(6) 2016 by tmc.The event description states: oxygenator was being used in cabg, when it was noted, it was not working properly.After oxygenator was replaced there appeared to be fiber "clot" in the device.

Manufacturer Narrative

Report is being submitted as follow up no.1 for mfg.Report no.9681834-2016-00063 to attach the maude adverse event report # mw5059640 that was inadvertently not attached in the initial report.

Event Description

This report is being submitted as follow up no.1 for mfg.Report no.9681834-2016-00063 to attach the maude adverse event report # mw5059640 that was inadvertently not attached in the initial report.

• Brand Name: CAPIOX FX15
• 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: 5500606
• MDR Text Key: 40333210
• Report Number: 9681834-2016-00063
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K130520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other