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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 Material Disintegration (1177)
Patient Problem No Patient Involvement (2645)
Event Date 03/01/2017
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). This medwatch report is being filed on behalf of livanova (b)(4). A livanova field service representative was dispatched to the facility to investigate. The service representative disassembled the unit and inspected the cardioplegia tank. Minor degradation of the cooling coils was identified. No degradation of the tubing or other materials in the tanks was observed. The customer reported that a disinfection procedure has been carried out and the unit has been used since the event without further issue. The device was reassembled and full functional checks were successfully performed. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The investigation is on-going. 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 black debris was identified in the cardioplegia heat exchanger during priming. The user believes the debris emanated from the heater-cooler system 3t. The heat exchanger and heater-cooler were swapped out to begin the procedure. 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 Key6433082
MDR Text Key70906193
Report Number9611109-2017-00243
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK052601
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
Report Date 03/24/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2017
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/03/2016
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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