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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 04/17/2020
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 livanova field service representative was dispatched to the facility to investigate the device and experienced a drive unit error code associated to a discrepancy between the set value and actual value of pump rpm. A loan device was provided to the customer. The affected device has been requested back to the manufacturer site for 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 that a centrifugal pump system with tubing clamp stopped during priming. 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
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 Key10057382
MDR Text Key194047633
Report Number9611109-2020-00306
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-01-00
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 Received05/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2011
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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