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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
Model Number 60-02-50
Device Problem Pumping Problem (3016)
Patient Problem No Patient Involvement (2645)
Event Date 08/29/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova deutschland 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. The scp panel was requested for further investigation. A visual inspection, a functional test and an hardware analysis were performed without detecting deviations: the unit worked as expected and within specification. No hardware failures were detected. Based on all the above facts, it cannot be ruled out that an intermittent connection between the motor control board and the hall sensor / pump control panel, contributed to the reported malfunction. It is likely that some mechanical change like temperature, vibration and / or physical stress of the panel led to the intermittent connections.
 
Event Description
Livanova received a report that an error code related to the drive unit of a centrifugal pump system with tubing clamp was displayed on the scp control panel during set-up. 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 Key9768521
MDR Text Key191697055
Report Number9611109-2020-00151
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
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 02/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2020
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 Received08/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2014
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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