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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 Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t displayed two error codes associated to patient pumps during procedure. There is not report of any patient injury.
 
Manufacturer Narrative
Patient information was not provided. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). The livanova field service representative in charge found both patient pumps defective and replaced the patient bridge assembly. 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.
 
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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 Key12788314
MDR Text Key284376377
Report Number9611109-2021-00633
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
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 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-85
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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