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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 Type  Death  
Manufacturer Narrative

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 an unknown city, most likely in (b)(6). If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Event Description

Through literature review livanova became aware of a (b)(6) years old male patient who undergone first cardiac surgery in 2004 outside of the facility stated in the article (b)(6) clinic). In 2011 the patient undergone another surgery for aortic valve replacement. Reportedly, no bacterial infection was suspected at the time of the surgery. He never fully recovered and presented notable fatigue, pancytopenia and liver disfuction. In 2014 he undergone cardiac surgery for the third time. It remain unclear from the article in which hospital the surgeries took place. Intraoperativly, he was found to have an aortic root abscess. Mycobacterium avium intracellulare grew from valve tissue several weeks after the surgery and also in pleaural fluid cultures aspirated a few days before the repeat surgery. The patient was started on a regimen of antibiotics in (b)(6) 2014. Twelve (12) months after his 2014 surgery he experienced progressive systemic symptoms such as fever, chills and night sweats. Acid-fast-bacilli test on bone marrow was negative. Despite medical therapy, the patient worsened. In (b)(6) 2015, the aortic root fluid cultures redemonstrated mycobacterium avium intracellulare. He was then transferred to (b)(6) clinic for further management where the m. Avium intracellulare was later specified as m. Chimaera. Per the patient's wishes, he returned to a facility closer to his home and passed away several months later.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
MDR Report Key10199501
MDR Text Key196557419
Report Number1718850-2020-01099
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 05/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2020
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Date05/28/2020
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/26/2020 Patient Sequence Number: 1
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