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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 Insufficient Heating (1287)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
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 service representative was able to confirm the reported issue and identified a broken wire on the end of the patient tank temperature sensor at the processor board connector. The technician replaced the temperature probe in the patient tank and re-calibrated all tank temperatures to resolve the reported issue. Subsequent functional verification testing was completed without further issues and the unit was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Evaluated by livanova representative.
 
Event Description
Livanova (b)(4) received a report that when the patient tank of a heater-cooler system 3t was set to 41 degrees, the temperature climbed above the set point and the alarm indicator lit up. The temperature indicator then began to fluctuate several degrees. When the set point was decreased to 37 degrees, the temperature indicator stabilized. The reported issue occurred 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 Key7639797
MDR Text Key112421103
Report Number9611109-2018-01071
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
Remedial Action Other
Type of Report Initial
Report Date 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2018
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2015
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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