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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number UNKNOWN
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 01/12/2015
Event Type  Death  
Manufacturer Narrative
Patient information was not provided. Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Livanova initiated an investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that a male patient undergone aortic valve replacement on (b)(6) 2015 and an heater-cooler system 3t was use. The serial number of the device used during surgery is unknown. Reportedly, patient showed signs of infection beginning in (b)(6) 2017 and he continued to experience symptoms throughout 2018 and 2019. Mycobacterium chimaera infection was diagnosed in (b)(6) 2020 and treated with courses of antibiotics. He was unable to undergo a second surgery and passed away (b)(6) 2020.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich
MDR Report Key12006547
MDR Text Key256422321
Report Number1718850-2021-01112
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 Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/07/2021,06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/07/2021
Event Location No Information
Date Report to Manufacturer09/07/2021
Date Manufacturer Received10/04/2021
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: 06/16/2021 Patient Sequence Number: 1
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