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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 Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4) manufactures the centrifugal pump system with tubing clamp. The incident occurred in (b)(6). The centrifugal pump system with tubing clamp was returned to (b)(4) for investigation and the reported issue could be reproduced. The malfunction was traced back to a faulty flow board, further replaced. Subsequent inspection was performed without further issue, and the unit was returned to the customer. The device was then requested back to (b)(4) for further investigation. During visual inspection no damages or issues were found on the returned board. The component was then connected to a system in the test bench. Power "on" was tested without problems. Different speeds were tested, with no problem identified. After 5 minutes since the test beginning, the flow display disappeared and only dashes were shown. Further analysis could not identify the final root cause for the board fault. The reported failure could be confirmed on the involved device and traced back to a defective flow board defective. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
 
Manufacturer Narrative
Livanova (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). The investigation is on-going. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
 
Event Description
Livanova (b)(4) received a report that the centrifugal pump system with tubing clamp displayed dashes (- - -) instead of flow during a procedure. The flow sensor was replaced but it did not resolved the issue. After replacing the entire control panel, the flow was displayed as expected. There was no report of patient injury.
 
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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 Key6788336
MDR Text Key251109068
Report Number9611109-2017-00628
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2017
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2012
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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