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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 Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 05/30/2018
Event Type  Malfunction  
Manufacturer Narrative

The heater-cooler 16-02-80 is not distributed in the usa. However, it is similar to the 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 event occurred in (b)(6). A livanova field service representative contacted the customer and was advised that the issue may be related to the stirrer motor. It was suggested to replace the stirrer. The customer has not reported whether the replacement has been conducted at this time. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device availability is unknown.

 
Event Description

Livanova (b)(4) received a report that the patient display of a heater-cooler system 3t displayed an error message during priming. The device could not be used. 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 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7630210
MDR Text Key112467551
Report Number9611109-2018-01067
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/22/2018
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 Received06/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/16/2015
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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