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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 16-02-85
Device Problem Electrical Power Problem (2925)
Patient Problem No Patient Involvement (2645)
Event Date 01/21/2021
Event Type  Malfunction  
Manufacturer Narrative

There was no patient involvement. Livanova (b)(4) manufactures the heater-cooler system (b)(4). The incident occurred in (b)(6). The technician in charge of the maintenance traced the fault back to a defective power supply. The part was replaced and the problem solved. Subsequent 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 heater-cooler system (b)(4) power failure during maintenance. There was no patient involvement.

 
Manufacturer Narrative

Reportability decision changed to not reportable event since, through follow up communication, livanova learned that the reported error was on cardioplegia side which is not likely to result in death or serious injury.

 
Event Description

See initial report.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindbergstrasse 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key11337083
MDR Text Key243922796
Report Number9611109-2021-00084
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK191402
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 02/17/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number16-02-85
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 Received02/23/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/16/2014
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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