MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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

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.

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.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, 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 Key: 6788336
• MDR Text Key: 83733361
• Report Number: 9611109-2017-00628
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1