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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY
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LIVANOVA USA, INC. 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY Back to Search Results
Model Number 3T
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 03/05/2019
Event Type  malfunction  
Event Description
Patient has coronary bypass surgery earlier this year in which the livanova 3t heater-cooler device was utilized during procedure.Patient presented to clinic a few months ago for evaluation of sternal wound and returned to surgery.Cultures from sternal wound tested positive with mycobacterium chimaera.Upon consult with the state and the center for disease control (cdc), it was recommended that this event be logged via fda medsun report.
 
Event Description
Patient has coronary bypass surgery earlier this year in which the livanova 3t heater-cooler device was utilized during procedure.Patient presented to clinic a few months ago for evaluation of sternal wound and returned to surgery.Cultures from sternal wound tested positive with mycobacterium chimaera.
 
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Brand Name
3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY
Manufacturer (Section D)
LIVANOVA USA, INC.
14401 west 65th way
arvada CO 80004
MDR Report Key9161605
MDR Text Key161421202
Report Number9161605
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number3T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2019
Date Report to Manufacturer10/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age22995 DA
Patient Weight116
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