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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 04/10/2017
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). No dhr and shr could be performed since no serial number was provided. No device, between the ones in use at the hospital, was upgraded with vacuum and sealing kit at the time of the surgery. Through follow-up communication with the chief perfusionist under 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 they are stored dry. This is not in alignment with current instruction for use however reportedly the devices in use at the hospital are very clean and there is no sign of biofilm. The devices are located inside the operating theater during use. The result of microbial sampling performed at customer site revealed that two devices in use at the hospital were found to be contaminated. It is not possible to determine if the device used for this specific surgery was one of the two devices confirmed to be contaminated. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova received report that a patient underwent cardiac surgery on (b)(6) 2017 and a heater-cooler 3t system was used. In (b)(6) 2018 patient developed raised areas with drainage from his sternal wound. The patient underwent wound exploration with an incision and drainage. Cultures from the (b)(6) 2018 wound exploration showed staphylococcus epidermis and cutibacterium acnes, and patient was treated with antibiotics. On (b)(6) 2018, cultures from (b)(6) 2018 wound exploration grew mycobacterium avium-intracellular complex. On (b)(6) 2019, mycobacterium avium-intracellular complex from the (b)(6) 2018 wound exploration was identified as mycobacterium chimaera.
 
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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
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key11663458
MDR Text Key245331803
Report Number9611109-2021-00209
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2021
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
Event Location No Information
Date Manufacturer Received04/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-2076/2081-2015

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