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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 Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 04/27/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (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 traced the failure to the stirrer, which was found to not start when the unit was powered on.Replacing the distribution board and loosening the pump motor fixings did not resolve the issue.It was determined that the stirrer motor was faulty and a new one was ordered.The service representative returned to the facility at a later date to install the new motor.Functional testing did not identify further issues and the unit was returned to service.The replaced stirrer motor was 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 replaced stirrer motor was returned to the original equipment manufacturer for investigation.The investigation identified that the motor shaft was stiff and the bearings were rusted.This was the cause of the reported issue.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM  80939
MDR Report Key7551362
MDR Text Key109746998
Report Number9611109-2018-00998
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16-02-80
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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