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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 Thermal Decomposition of Device (1071); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 04/13/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. 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. The technician identified that the blocked patient pump led to a burned resistor on the distribution board. The patient pump and distribution board were replaced to resolve the reported malfunction. 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. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error code and smoke was observed exiting the device during maintenance. There was no patient involvement.
 
Manufacturer Narrative
The defective pump was returned to livanova (b)(6) for further investigation. The visual inspection revealed that the pump is dirty and the electronics on the pump is defective.
 
Manufacturer Narrative
In the initial report was reported that: "the technician identified that the blocked patient pump led to a burned resistor on the distribution board. The patient pump and distribution board were replaced to resolve the reported malfunction. " the correct narrative is as below: "the technician found out burnt resistor on the distribution board so he replaced it but also the new board burnt out. Thus, he identified that the patient pump was damaging the boards. The patient pump and distribution board were replaced to resolve the reported malfunction. " investigation results revealed that both distributor boards had high impedance resistors. The pump motor electronics defects were most likely caused by the overfilling of the machine. Defective pump circuit boards damaged the resistors on the distributor boards causing the reported event.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 89309
Manufacturer Contact
njemile crawley
14401 w. 65th way
arvada, CO 80004
2812287575
MDR Report Key7551423
MDR Text Key109516948
Report Number9611109-2018-00999
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,Followup,Followup
Report Date 04/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2018
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? No
Event Location No Information
Date Manufacturer Received04/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2008
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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