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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 60-02-50
Device Problem Pumping Problem (3016)
Patient Problem No Patient Involvement (2645)
Event Date 08/20/2020
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 review of the dhr could not identify any deviations, or nonconformities relevant to the issue. A livanova field service representative was dispatched to the facility to investigate the device, and could confirm the reported issue. The unit was requested back to the manufacturer site for investigation. Results confirmed the reported problem. The panel was disassembled and the shaft angle encoder was replaced. The failure was solved.
 
Event Description
Livanova received a report stating that a centrifugal pump system with tubing clamp displayed an error code associated to the shaft angle encoder during the set-up. The issue did not improve by turning the power off/on and by reconnecting the plug. 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
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 Key10545749
MDR Text Key208217749
Report Number9611109-2020-00529
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeJA
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 09/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-02-50
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 Received08/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2009
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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