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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 Smoking (1585); Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. 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) manufactures the heater-cooler system 3t. The incident occurred in (b)(4). A livanova technician investigated the device and traced the fault back to the stirrer motor which was replaced. The problem was solved. Subsequent functional verification testing was completed without further issues and the unit was returned to service. The most likely root cause s related to bearing damage due to environmental conditions in which the motor worked which may led to corrosion preventing the motor from rotating freely.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error message associated to the stirrer motor after routine disinfection cycle. Smoke was reportedly coming out from the rear fan grid. There was no patient/user involvement.
 
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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 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10902923
MDR Text Key218217726
Report Number9611109-2020-00651
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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