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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 16-02-95
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/27/2021
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. The heater-cooler 16-02-95 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402). 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 confirm the reported issue. The failure was traced back to stuck patient pumps. The patient bridge was replaced and problem was solved. Subsequent functional verification testing was completed without further issues and the unit was returned to service. The reported issue was most likely due to rust formation generating irregularities on the surface of the balls of the bearing. Possible causes are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t water flow issues on patient side during maintenance. 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 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key11736394
MDR Text Key268250898
Report Number9611109-2021-00230
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-95
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2019
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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