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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 16-02-85
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 03/06/2019
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). Through follow-up communication with the chief perfusionist related to previous cases from the same hospital, livanova (b)(4) learned that the water in the heater-cooler systems 3t in use is changed every day and the device are stored dry. This is not in alignment with current instruction for use however reportedly the devices are very clean and there is no sign of biofilm. The devices are located inside the operating theatre during use. Two (2) over five (5) devices which were in use at the hospital resulted to be contaminated. Only one serial number has been provided ((b)(4)) and a follow up report for the cases associated to this specific device has been filed. The second serial number remains unknown as well as the type of contamination. 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 underwent a cardiac surgery on (b)(6) 2019 and an heater-cooler system 3t was used. The patient was possibly infected with m. Chimaera. However, no information if this was diagnosed has been provided. The patient died on (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 80309
GM 80309
MDR Report Key11453828
MDR Text Key238875282
Report Number1718850-2021-01033
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
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16-02-85
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 Date02/10/2021
Device Age4 YR
Event Location Hospital
Date Manufacturer Received02/10/2021
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: 03/10/2021 Patient Sequence Number: 1
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