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

Model Number 3CX*FX15RW30C

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 09/21/2017

Event Type  Death  

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.(b)(4).Results: results pending completion of evaluation.Conclusion: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was no oxygenation when they were using full flow to the patient.The patient was on bypass for a few hours on/off with no issue.They had to keep increasing oxygen and air gas flow.On the last run of bypass, they were using full flow to the patient but there was no oxygenation.However, once they dropped the flow to under 1/2 flow, they were able to oxygenate normally.They stopped using bypass and went on ecmo to complete the surgery.The patient later passed away but the perfusionist has confirmed that this was not related to the reported oxygenator failure.Death; 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 october 13, 2017.Upon further investigation of the reported event, the following information is new and/or changed: (device availability - date returned to manufacturer), (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information), (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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.(b)(4).Visual inspection upon receipt did not find any anomalies that could have caused a gas leak or insufficient gas transfer performance.Gas transfer performance was tested on the actual sample, during which no anomalies were found and the unit met factory specifications.A review of the device history revealed no production related anomalies.The issue is likely due to the wet lung phenomenon or plasma leak occurrence wherein water condensation occurs inside the fibers of micro porous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.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 CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6947636
• MDR Text Key: 89253142
• Report Number: 1124841-2017-00208
• 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,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: UN07
• Other Device ID Number: (01)00699753450783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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
• Patient Outcome(s): Death