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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA SORIN GROUP PERFUSION SYSTEM HEATER COOLER 3T DEVICES

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LIVANOVA SORIN GROUP PERFUSION SYSTEM HEATER COOLER 3T DEVICES Back to Search Results
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Date 03/07/2014
Event Type  Injury  
Event Description
This patient was identified as acquiring a mycobacterium chimaera infection likely associated with use of the sorin group perfusion system - heater cooler 3t devices.
 
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Brand NameSORIN GROUP PERFUSION SYSTEM
Type of DeviceHEATER COOLER 3T DEVICES
Manufacturer (Section D)
LIVANOVA
14401 west 65th way
arvada CO 80004
MDR Report Key6093870
MDR Text Key59772364
Report Number6093870
Device Sequence Number1
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/07/2014,11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/02/2016
Distributor Facility Aware Date11/02/2016
Event Location Hospital
Date Report to Manufacturer11/02/2016
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/03/2016 Patient Sequence Number: 1
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