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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 Problems Thermal Decomposition of Device (1071); Failure to Pump (1502); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 09/20/2017
Event Type  malfunction  
Manufacturer Narrative
Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). A livanova field service representative was dispatched to the facility to investigate. The service representative was able to confirm the reported issue and found that water was spilled into the device during the disinfection procedure, causing internal damage. The device was determined to be non-repairable and has been removed from service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t displayed multiple error messages and developed a burning smell during priming. The pumps also reportedly did not turn. There was no patient involvement.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w .65th way
arvada, CO 80004
2812287260
MDR Report Key6972798
MDR Text Key90760293
Report Number9611109-2017-00856
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 10/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-80
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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