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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 Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in london, united kingdom.A livanova field service representative was dispatched to the facility to investigate the device and could reproduce the reported error.After removing the covers of the machine it was visible that the stirrer motor (pump 1) was not rotating as expected.In order to solve the issue, stirrer motor and distribution board were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova deutschland received a report that a heater-cooler system 3t displayed an error message associated to stirring mechanism that did not start (power consumption was too low), during priming.There was no patient involvement.
 
Manufacturer Narrative
Complaint database review revealed that unit was installed in 2017 and no further similar issues were reported.Based on all the gathered information, it cannot be ruled out that a failure of the stirrer motor, no longer able to turn freely, have resulted in a problem with the boards too.In deeper details, it can be assumed that a (partially) blocked motor, likely due to wear of the bearing or corrosion/degradation or also environmental conditions, as water infiltration, humidity, condensation or high temperatures, led the machine to request for an electrical power overload, which could have resulted in an over-current that ultimately damaged the board.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
 
Event Description
See intial report.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80939
GM  80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80939
GM   80939
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key19041814
MDR Text Key340118552
Report Number9611109-2024-00169
Device Sequence Number1
Product Code DWC
UDI-Device Identifier04033817901099
UDI-Public(01)04033817901099(11)170530
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 04/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16-02-80
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received04/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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