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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 60-02-15
Device Problem No Device Output (1435)
Patient Problem No Patient Involvement (2645)
Event Date 02/17/2017
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. (b)(4) manufactures the centrifugal pump system with tubing clamp. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). A livanova field service representative was dispatched to the facility to investigate. The service representative confirmed the reported issue and traced the problem to the flow board. The flow board was replaced to resolve the issue and a complete functional verification was successfully completed. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The investigation is on-going. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Not returned to manufacturer.
 
Event Description
Livanova (b)(4) received a report that there was no indication of flow on the centrifugal pump system with tubing clamp during priming. The display showed 00. 0. The pump was switched out to complete the case. 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, 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6408291
MDR Text Key70076910
Report Number9611109-2017-00178
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
Remedial Action Other
Type of Report Initial
Report Date 03/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-02-15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2005
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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