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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 Pumping Problem (3016)
Patient Problem No Patient Involvement (2645)
Event Date 10/26/2020
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)(6). The technician in charge replaced the distribution board and the patient pump 2 to solve the problem. Subsequent functional verification testing was completed without further issues and the unit was returned to service. A mechanical/electronic failure of the motors circuit boards caused the reported issue.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t displayed error messages associated to patient circuit during maintenance. 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 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10903175
MDR Text Key218643852
Report Number9611109-2020-00649
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeSP
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
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 Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2016
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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