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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 Failure to Pump (1502)
Patient Problem No Patient Involvement (2645)
Event Date 12/13/2018
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). 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 traced the failure to a defective pump bearing. The technician replaced the pump to resolve the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t patient pump did not work during maintenance. 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
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 89309
GM 89309
Manufacturer Contact
barbara galasso
lindberghstr. 25
munich, CO 89309
2812287260
MDR Report Key8260103
MDR Text Key133536313
Report Number9611109-2019-00038
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
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,Followup
Report Date 05/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/18/2019
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 Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/26/2012
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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