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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA PLC STOCKERT /SORIN LIVANOVA PLC STOCKERT 3T HEATER-COOLER SYSTEM HEATER COOLER

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LIVANOVA PLC STOCKERT /SORIN LIVANOVA PLC STOCKERT 3T HEATER-COOLER SYSTEM HEATER COOLER Back to Search Results
Model Number 3T
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bacterial Infection (1735); Fever (1858)
Event Date 07/17/2017
Event Type  Injury  
Event Description

Fever and bacteremia with non-tuberculous mycobacterium chimaera that developed 18 months after the pt underwent open-heart surgery during which a liva nova plc stockert 3t heater cooler system was used for temperature control.

 
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Brand NameLIVANOVA PLC STOCKERT 3T HEATER-COOLER SYSTEM
Type of DeviceHEATER COOLER
Manufacturer (Section D)
LIVANOVA PLC STOCKERT /SORIN
GM
MDR Report Key6806759
MDR Text Key83204232
Report NumberMW5071677
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number3T
Device Catalogue Number16-02-85
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/21/2017 Patient Sequence Number: 1
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