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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-02-15
Device Problems Thermal Decomposition of Device (1071); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2018
Event Type  malfunction  
Manufacturer Narrative
Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp. The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate. The service representative was able to confirm the reported issue and traced the failure to a defective flow board. The technician replaced the flow board and the flow sensor to resolve the reported issue. Subsequent functional verification testing was completed without further issues and the unit was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
 
Event Description
Livanova (b)(4) received a report that a centrifugal pump system with tubing clamp did not work and released a burning smell during procedure. There was no report of patient injury.
 
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Brand NameCENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7352405
MDR Text Key103178386
Report Number9611109-2018-00245
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-02-15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2013
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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