MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Leak/Splash (1354)

Patient Problems Autoimmune Disorder (1732); Death (1802); Lupus (1956)

Event Date 12/05/2019

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).

Event Description

The user facility reported to terumo cardiovascular, that during cardiopulmonary bypass (cpb) a plasma leak was observed.Per user facility, the patient was in for davinci robotic removal of left atrial myxoma and the closure of a patent foramen ovale (pfo) with complications that resulted in over 9 hours on cardiopulmonary bypass support.Per user facility there was no performance degradation in the first unit.The unit was changed out after 6.5 hours, however because of patient's instability, cpb was reinitiated and they were on bypass for another 3 hours.The second unit developed a plasma leak again with no downturn in gas exchange performance.The patient was weaned from bypass on the second oxygenator with an attempt of extracorporeal membrane oxygenation (ecmo).The patient received lots of blood and crystalloid however did not survive the procedure.In addition according to user facility given the patient¿s history, copious amounts of transfusion, no performance degradation and the length of time on cpb.They were not surprised that some plasma leakage would occur.It is unknown it there was delay.It is unknown if there was blood loss.

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 january 10, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 4114, 3221, 4315).The affected sample was not returned, so a thorough investigation could not be performed and a definitive root cause could not be determined.A review of device history record and incoming inspection record of the involved material code or lot number confirmed that there were not any indications of anomaly in them.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC 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: 9577239
• MDR Text Key: 174567377
• Report Number: 1124841-2020-00010
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: XD25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 65