MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available - evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, the perfusionist noticed a crack in the arterial side stop cock of the sampling port.No patient involvement as this occurred during setup.Product was changed out.Surgery 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 december 19, 2016.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned sample was visually inspected.A crack along the female l-shaped connector was found, while still connected to the luer port.A retention sample from the same product code and lot number combination was visually inspected and confirmed to not have any damages or cracks on the l-shaped connector.Replication testing was performed on a retention sampling manifold line.The l-connector was over-tightened onto a port of the reservoir, which lead to the l-connector cracking along the part, in the same way as the returned sample.It is likely that during setup of the circuit, the l connector been over-tightened, causing it to crack.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6187036
• MDR Text Key: 62793315
• Report Number: 1124841-2016-00432
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• 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: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: UA25
• Other Device ID Number: (01)00699753450783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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