MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Complete Blockage (1094)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2017

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.For this reason, terumo references (b)(4).

Event Description

The user facility reported to terumo cardiovascular that during prime, the pigtail of the plegia port was clogged.  *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.The returned sample was visually inspected.No damages were present in the affected area of the product.No other visual anomalies were noted.A syringe filled with water was attached to the luer port at the end of the pigtail line, and then an attempt was made to push water through the line.This was unsuccessful confirming the blocked port.Additionally, water was placed into the blood outlet port of the oxygenator and attempted to be pulled through the pigtail line; this was also unsuccessful.A retention sample of the same product code and lot number combination was retrieved.Visual inspection of the retention sample concluded with no noted visual anomalies.The retention sample was tested with positive and negative flow through the pigtail line, and each attempt passed.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 block the port.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6996424
• MDR Text Key: 91926290
• Report Number: 1124841-2017-00229
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

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: 06/30/2020
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: VH24
• Other Device ID Number: (01)00699753450820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• 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