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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 Problems Electrical /Electronic Property Problem (1198); Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Date 07/11/2017
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601). This event was initially considered to be non-reportable. However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable. This report is being filed as part of a retrospective review conducted in response to this new decision. 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 could not confirm the reported failure but reported the unit tripping the rcd as soon as the cooling unit started. The service representative determined the fault to be a tripping compressor caused by fluid ingress from the cooling coils in the tank. The unit was recommended to be returned to livanova (b)(4) for further investigation and repair. During investigation a hole inside the evaporator was identified as root cause of the reported failure. A review of the dhr could not identify any deviations or nonconformities relevant to the issue. Corrective actions are in progress for this issue.
 
Event Description
Livanova (b)(4) received a report that the heater cooler 3t system did not cool the cardioplegia tank and that a bubbling sound came from the unit during setup. 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
lindbersghtr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7106278
MDR Text Key95740810
Report Number9611109-2017-00994
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUK
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 12/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-80
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2015
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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