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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 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) 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). 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 m. Chimaera infection retrospective study conducted in (b)(6). Within the article is stated that 9 patients resulted to be infected with m. Chimaera. This report captures 4 over 9 cases since five (5) of those were already registered in livanova database and already reported under mfr report numbers: 9611109-2015-00525, 9611109-2015-00624, 9611109-2017-00205, 9611109-2017-00279, 9611109-2018-00165. Within the article it is stated that 2 patient recovered and the other 7 are still under treatment. These patients had undergone valve replacement in several hospitals between 2007 and 2015 and presented with endocarditis with or without aortic root abscess or dissemination, deep surgical site infection, spinal osteomyelitis and disseminated disease. Heater-cooler systems 3t , hcu30s and hcu40s were used during the mentioned surgeries (between 2007 and 2015). Thirtyfive (35) heater-cooler systems 3t , six (6) hcu30s and four (4) hcu40s were sampled at several hospital between february and august 2015 and twentyseven (27) 3ts, three(3) hcu40s and four (4) hcu30s were found positive to mycobacteria. Among those, seventeen (17) 3ts, one (1) hcu30 and one (1) hcu40 were positive to m. Chimaera. It is unclear if these sampled devices were including the ones actually used for the above mentioned surgeries. The hospitals where the surgeries took place and the serial numbers of the devices used during the procedures are unknown.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
14401 w. 65th way
arvada 80004
GM 80004
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10157645
MDR Text Key199844278
Report Number9611109-2020-00350
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Other Health Care Professional
Remedial Action Recall
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 Number16-02-80
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 Received05/20/2020
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

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