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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA (FORMERLY SORIN GROUP, S.P.A.) SORIN 3T PERFUSION HEATER-COOLER THERMAL REGULATOR DEVICE

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LIVANOVA (FORMERLY SORIN GROUP, S.P.A.) SORIN 3T PERFUSION HEATER-COOLER THERMAL REGULATOR DEVICE Back to Search Results
Model Number 3T
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Type  malfunction  
Event Description
Sorin 3t perfusion heater-cooler tested positive for non-tuberculous mycobacteria. Hospital has not identified any related infections in patients. The device has been sequestered and disinfected pursuant to manufacturer recommendations and continues to receive recommended activities at recommended intervals. Microbiological sampling is being done continuously and passing results are pending.
 
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Brand NameSORIN 3T PERFUSION HEATER-COOLER
Type of DeviceTHERMAL REGULATOR DEVICE
Manufacturer (Section D)
LIVANOVA (FORMERLY SORIN GROUP, S.P.A.)
via benigono crespi, 17
milano 20159
IT 20159
MDR Report Key5764538
MDR Text Key48634922
Report NumberMW5063182
Device Sequence Number1
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3T
Device Catalogue Number16-02-85
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
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: 06/29/2016 Patient Sequence Number: 1
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