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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 Problem Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
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 device and found that the alarm was caused by the stirrer pump not rotating.After reassembling the pump motor to the pump head at the stirrer shaft and pushing up the impeller the pump motor shaft rotated freely.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error message associated to the stirrer motor.There was no patient involvement.
 
Event Description
See initial report.
 
Manufacturer Narrative
H10: the reported blockage was most likely due to a misalignment between the motor shaft and the impeller that did not allow free rotation.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key11051061
MDR Text Key223722637
Report Number9611109-2020-00701
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K191402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16-02-85
Was the Report Sent to FDA? No
Date Manufacturer Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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