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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA PLC (FORMERLY SORIN GROUP DEUTSCHLAND GMB) SORIN 3T HEATER/COOLER DEVICE TEMPERATURE CONTROLLER

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LIVANOVA PLC (FORMERLY SORIN GROUP DEUTSCHLAND GMB) SORIN 3T HEATER/COOLER DEVICE TEMPERATURE CONTROLLER Back to Search Results
Device Problem Contamination (1120)
Patient Problem Bacterial Infection (1735)
Event Date 03/18/2016
Event Type  Injury  
Event Description
Mycobacterium canariasense isolated from a pt who had open heart surgery and the sorin 3t heater/cooler device was used in the case.
 
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Brand NameSORIN 3T HEATER/COOLER DEVICE
Type of DeviceTEMPERATURE CONTROLLER
Manufacturer (Section D)
LIVANOVA PLC (FORMERLY SORIN GROUP DEUTSCHLAND GMB)
MDR Report Key6260437
MDR Text Key65318140
Report NumberMW5067285
Device Sequence Number1
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/16/2017 Patient Sequence Number: 1
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