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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 16-02-82
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2021
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 could not confirm 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 displayed an error message associated to a patient pump during support. The device was replaced with another one. There was no report of patient injury.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key13075891
MDR Text Key285387474
Report Number9611109-2021-00720
Device Sequence Number1
Product Code DWC
UDI-Device Identifier04033817900511
UDI-Public0104033817900511111605202116S16838
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K191402
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 12/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-82
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2016
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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