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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 Pumping Problem (3016)
Patient Problems No Patient Involvement (2645); Not Applicable (3189)
Event Date 02/16/2018
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 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.

 
Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t patient pump stopped working during in-service. 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
14401 w. 65th way
arvada 80004
GM 80004
Manufacturer Contact
njemile crawley
14401 w. 65th way
arvada, CO 80004
2812287575
MDR Report Key7333874
MDR Text Key102461746
Report Number9611109-2018-00217
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeAU
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,Followup
Report Date 03/20/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2018
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? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/16/2017
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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