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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 Problems Bacterial Infection (1735); Death (1802)
Event Date 05/22/2020
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided. The date of the event will be provided in a supplemental report if made available. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available 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 under previous cases from the same hospital livanova learned that the water in the heater-cooler systems 3t in use is changed every day and they 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. We are currently waiting to know the result of microbial sampling performed at customer site. Reportedly the tests are still in progress. 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 of three (3) more patients infected with mycobacteria at university of (b)(6) medical center. The type of bacteria has not been specified, the serial number of the devices used and the date of surgeries are currently unknown.
 
Manufacturer Narrative
The serial numbers of the devices used for these surgery are unknown. However, 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 other 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
See initial report.
 
Manufacturer Narrative
This report originally captured three (3) patient infections. Through follow-up communication livanova became aware of additional information and a single complaint has been generated per each event. In detail, this report is now capturing only one (1) over three (3) event related to a female patient infected with mycobacteria chimaera. The patient undergone cardiac surgery for aortic valve replacement in (b)(6) 2019. Despite antibiotics therapy, patient died in (b)(6) 2020. The serial number of the device used during procedure is unknown. The remaining two (2) cases are being reported under the following importer references: 1718850 -2020-01216, 1718850 -2020-01217.
 
Event Description
See initial report.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key10195790
MDR Text Key199071251
Report Number1718850-2020-01097
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,Followup
Report Date 06/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2020
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 Date11/12/2020
Event Location No Information
Date Manufacturer Received05/28/2020
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?
Type of Device Usage Invalid Data

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