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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 Problems Insufficient Cooling (1130); Insufficient Heating (1287)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2018
Event Type  malfunction  
Manufacturer Narrative
This report was initially submitted on (b)(6) 2018. The report was rejected due to an incorrect code and will no be resubmitted. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Following the event, the facility biomedical engineer tested the device and found the unit to warm and cool according to specification. A livanova field service representative was dispatched to the facility to investigate. The service representative was unable to confirm the reported issue. Extensive testing was performed and all temperatures were reached within the specified time limits. The device worked according the specification and was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. As the issue could not be reproduced, a root cause was not identified. Device not returned.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t did not sufficiently warm or cool during a procedure. There was no report of patient injury.
 
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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 Key7709624
MDR Text Key114688512
Report Number9611109-2018-01092
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052601
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 07/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received06/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2017
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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