MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX RES ONLY; BLOOD GAS OXYGENATOR

Model Number 3ZZ*R4000C

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up, it appears to be glue on the attachment of the reservoir.No patient involvement.Product was changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations - and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on june 2, 2016.Method: actual device evaluated; visual inspection.Results: non-functional defect.Conclusions: human factors issue.The actual sample was returned for evaluation.During visual inspection, it was confirmed that excess dried bonding agent was on the tubing outside the connected port.No damages were present in the affected area of the product.The cause of the issue is that there was excess bonding agent on the tubing when it was inserted into the port.This is not a functional issue as the excess bonding agent does not cause any damage to the tubing or port.Review of the device history records revealed no manufacturing issues.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: NS FX RES ONLY
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5695540
• MDR Text Key: 46470311
• Report Number: 1124841-2016-00238
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 3ZZ*R4000C
• Device Catalogue Number: N/A
• Device Lot Number: UC15
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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