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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. SORIN HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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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.
 
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Brand Name
SORIN HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA USA, INC.
14401 west 65th way
arvada CO 80004
MDR Report Key8539239
MDR Text Key142752877
Report Number8539239
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/2019
Event Location Hospital
Date Report to Manufacturer04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age20805 DA
Patient Weight97
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