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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-80
Device Problem Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 10/11/2019
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)(6). A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported problem. The plastic insulation of the neutral pin of the plug was melted. According to the technician this was likely caused by a loosening of the wire in the connector. A new mains plug was fitted and the issue solved. Functional verification testing was completed without further issues and the unit was returned to service.

 
Event Description

Livanova (b)(4) received a report of a melted plug of a heater-cooler system 3t. The user also reported that also the theatre mains wall socket was slightly damaged. 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 GMBH
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key9294363
MDR Text Key168711579
Report Number9611109-2019-00879
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
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2019
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? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2018
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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