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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 Problems Thermal Decomposition of Device (1071); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 04/12/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate. The service representative was able to confirm the reported issue and traced the failure to a faulty patient pump. The pump was replaced to resolve the reported issue. Subsequent functional verification testing was completed without further issues and the unit was returned to service. The replaced pump has been requested for return to livanova (b)(4) for further investigation. 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.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error message on the patient side during maintenance. There was no patient involvement.
 
Manufacturer Narrative
The pump was returned to livanova (b)(4) for further investigation. The evaluation results revealed that the pump was very dirty and that the pump motor board was found to be defective.
 
Event Description
See initial.
 
Manufacturer Narrative
In the initial report, submitted may 22, 2018, it was inadvertently not reported that in addition to the faulty pump, a burnt resistor was also discovered on the distribution board. Further evaluation revealed that the blocked pump was the cause of the burnt resistor.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
njemile crawley
14401 w. 65th way
arvada, CO 80004
2812287575
MDR Report Key7535323
MDR Text Key109228453
Report Number9611109-2018-00978
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 04/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-85
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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