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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND GMBH CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 06/26/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp. The event occurred in (b)(6). The livanova representative replaced the motor control board and the issue could be solved. Functional verification testing was completed without further issues and the unit was returned to service. A defect on the replaced board led to the reported event.
 
Event Description
Livanova received a report that during regular annual maintenance a centrifugal pump system with tubing clamp was giving an error code. There was no patient involvement.
 
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Brand NameCENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key9680447
MDR Text Key196436385
Report Number9611109-2020-00071
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeIT
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 02/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received06/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2015
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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