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 Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2016

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 during cardiopulmonary bypass, there is excess bonding material on the pigtail that attaches to the venous inlet port of the fx advance reservoir.The excess bonding material makes it appear to be a defect at the bonding site that may cause the tubing to break off the connection.The customer was afraid to touch it as they thought it might disconnect.No known impact or consequence to patient.Product was not 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 17, 2016.Upon further investigation of the reported event, the following information is new and/or changed.(b)(4).The actual device was returned for evaluation.Review of the device history records revealed no manufacturing issues.The returned sample was visually inspected.Visual inspection of the returned sample confirmed the presence of excess bonding agent on the tubing around the port of the venous line on the venous inlet.No damages were present in the affected area of the product.The cause of the event is excess bonding agent on the tubing when it is inserted into the port, causing the bonding agent to be pushed down the outside of the tubing by the port.The bonding agent then dries on the outside of the tubing allowing it to be visible by the customer.This is not a functional issue, but is rather a cosmetic issue only.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: 5732943
• MDR Text Key: 47656523
• Report Number: 1124841-2016-00250
• 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: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 3ZZ*R4000C
• Device Catalogue Number: N/A
• Device Lot Number: UD21
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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