MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE40C

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the 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 when more information becomes available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, approximately 2 hours into a 5 hour pump run, condensation and fluid were observed inside the end cap of the oxygenator.There was also fluid dripping around the end cap and some blood in the gas inlet line to the oxygenator.Blood loss amount is unknown.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 september 4, 2018.(b)(4).The sample was not returned for evaluation, however, a video showing the complaint was provided for review.A retention sample was visually inspected and did not reveal any obvious anomaly such as a break.The retention sample was also built into a circuit with tubes and saline solution was circulated in the circuit at the flow rate of 5l/min.No leak was observed.Subsequently, the circuit was circulated with bovine blood for 6 hours at the flow rate of 5l/min and at the back pressure of 500 mmhg.After the 6-hour circulation, a gas was sent into the gas phase.No leak was observed.A review of the video confirmed the event.The presence of foamy fluid was noted around the gas phase.Based on the review result of the provided video, it is likely that a plasma leak took place in the actual sample.With the absence of the actual sample to evaluate, however, it is difficult to determine the definitive cause of this complaint.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7844858
• MDR Text Key: 119153110
• Report Number: 1124841-2018-00213
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450813
• UDI-Public: (01)00699753450813
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: WF28
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1