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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 Type  Injury  
Manufacturer Narrative
Patient information was not provided. 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. The heater-cooler 16-02-80 is not distributed in the usa, and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402). Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred 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 learned about a (b)(6) years old male patient infected with mycobacterium chimaera. He underwent placement of a heartmate ii lvad via median sternotomy with normothermic cardiopulmonary bypass. He required device exchange 4 years later for pump stoppage due to electrical failure, and this was performed via redo-sternotomy with normothermic cardiopulmonary bypass. One year later he presented with a right-sided abdominal wall fluid collection contiguous with the internal driveline tunnel. The fluid was drained percutaneously and acid-fast bacilli were noted on microscopy. Treatment with azithromycin, ethambutol, and rifampin was initiated and mycobacterial culture was positive for m. Chimaera. Debridement and a delayed flap coverage of exposed hardware was performed. Within several weeks of the procedure, the patient developed abdominal wall cellulitis and wound drainage, requiring incision and drainage and treatment with additional broad spectrum antibiotics. He is followed as an outpatient, now 3 months after presenting with the m. Chimaera device-related infection. The date of surgery is between 2011 and 2016 and a heater-cooler 3t device was used.
 
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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 Key10157655
MDR Text Key195654349
Report Number1718850-2020-01096
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 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
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 Date05/20/2020
Event Location No Information
Date Manufacturer Received05/20/2020
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

Patient Treatment Data
Date Received: 06/16/2020 Patient Sequence Number: 1
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