LIVANOVA USA, INC. SORIN HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Death (1802); Unspecified Infection (1930)
|
Event Date 11/28/2017 |
Event Type
Death
|
Event Description
|
Mitral valve replacement.We were notified that this patient expired, and the patient had tested positive for m.Chimera.The patient had a mitral valve replacement approximately 15 months prior and a heater-cooler unit was used in this procedure.
|
|
Event Description
|
Mitral valve replacement.We were notified that this patient expired, and the patient had tested positive for m.Chimera.The patient had a mitral valve replacement approximately 15 months prior and a heater-cooler unit was used in this procedure.It is our understanding that this unit was manufactured in approximately may 2017 and was provided to our facility in july 2017 by the manufacturer as part of a loaner program.The unit was sent back to the manufacturer on 03/2019 for issues unrelated to potential contamination.
|
|
Search Alerts/Recalls
|
|
|