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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 Problems Electrical Shorting (2926); Unexpected Shutdown (4019)
Patient Problem No Patient Involvement (2645)
Event Date 02/07/2020
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). Livanova field service representative was dispatched to the facility and confirmed the reported malfunction. He traced the failure back to a defective compressor.

 
Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t was tripping the fuse when the compressor was activated to cool down the tanks. The issue was identified after the procedure. Livanova (b)(4) received a report that a heater-cooler system 3t.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80309
GM 80309
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 Key9792723
MDR Text Key197133408
Report Number9611109-2020-00169
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeAS
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 03/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2020
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 Received02/10/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/20/2015
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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