MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; BLOOD GAS OXYGENATOR

Model Number UNKNOWN

Device Problem Leak/Splash (1354)

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

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: g4 (date received by manufacturer), g7 (indication that this is a follow-up report), h2 (follow-up due to additional information), h6 (identification of evaluation codes 4114, 3221, 4315), method code: 4114 - device not returned, results code: 3221 - no findings available, conclusions code: 4315 - cause not established.The affected sample was not returned, so a thorough investigation could not be performed and a definitive root cause could not be determined.Since the product code was unknown, device history record and incoming inspection record could not be reviewed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9577200
• MDR Text Key: 174558823
• Report Number: 1124841-2020-00009
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• 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

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: XA19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 65