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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 16-02-80
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Type  Death  
Manufacturer Narrative
Patient information was not provided. 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) 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). Livanova will attempt to retrieve additional information about the reported event. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) became aware through literature review of m. Chimaera isolate obtained from a bone marrow specimen taken from a (b)(6)-year-old man hospitalized in (b)(6) 2013 with a two-month history of progressive kidney failure, increased liver enzyme levels, pancytopenia and splenomegaly. Fever was recorded at admission and microbiological samples and transthoracic echocardiography findings were initially negative. A bone marrow aspirate performed due to progressive deterioration and pancytopenia did not reveal granulomas, and haemophagocytic syndrome was ruled out. Four weeks after the patient was admitted, a mac isolate was obtained from the bone marrow samples. Blood and urine cultures were negative for mycobacteria. Transoesophageal echocardiography performed at the time of mac isolation showed mitral valve vegetation, and the patient started treatment with ethambutol, clarithromycin and rifampicin, with rapid resolution of fever. Surgical treatment was considered but rejected due to the patient¿s terminal condition. The patient died a few days later. Within the article it is stated that a subsequent search of his clinical history revealed aortic valve replacement and mitral repair in (b)(6) 2012.
 
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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
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10132946
MDR Text Key194480463
Report Number9611109-2020-00339
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 05/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16-02-80
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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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