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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 60-01-00
Device Problem Pumping Stopped (1503)
Patient Problem No Patient Involvement (2645)
Event Date 03/19/2019
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.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 and could confirm the reported issue.He traced the failure back to a defective motor circuit board.The part was replaced and the issue solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The affected part has been requested back to livanova (b)(4) for a detailed investigation.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 of a centrifugal pump system with tubing clamp not keeping the speed, stopping after few seconds and displaying an error message during priming.There was no patient involvement.
 
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Brand Name
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 89309
GM  89309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 89309
GM   89309
Manufacturer Contact
njemile crawley
14401 w. 65th way
arvada, CO 80004
2812287575
MDR Report Key8521677
MDR Text Key142178506
Report Number9611109-2019-00262
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K032213
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
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number60-01-00
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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