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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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 12/19/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601). 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 service representative was not able to confirm the reported error message. However during evaluation of the device it was found that the float assembly was bent. This issue could be determined as root cause for the incorrect displayed values. The service representative replaced the float assembly to resolve the reported malfunction. Subsequent functional verification testing was completed without further issues and the unit was returned to service. A review of the dhr could not identify any deviations or nonconformities relevant to the 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 and it was found that the level indicator was showing incorrect values during the device user 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
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
njemile crawley
14401 w. 65th way
arvada, CO 80004
2812287575
MDR Report Key8252351
MDR Text Key133360914
Report Number9611109-2019-00035
Device Sequence Number1
Product Code DWC
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,Followup
Report Date 03/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-80
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 Received02/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2013
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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