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

Model Number 60-02-50

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).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 a s5 system displayed an error message during procedure.There was no report of patient injury.

Manufacturer Narrative

Initially it was reported that the issue is related to a s5 system which was incorrect.The correct device is a centrifugal pump system with tubing clamp.Control, pump speed, cardiopulmonary bypass.60-02-50, 60s08704.Pma/510k: k032213.Device manufacture date: 24.01.2011.

Manufacturer Narrative

The customer requested that a replacement scp control panel be provided to be installed by the user.The panel was provided and successfully installed.Subsequent functional verification testing found no further issues.The replaced device was returned to livanova usa for further investigation.The reported issue could not reproduced during visual inspection and functional testing.As the issue could not be reproduced, a root cause could not be determined and no corrective actions were identified.A review of the dhr did not identify any deviations or non-conformities relevant to the 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
• MDR Report Key: 7205056
• MDR Text Key: 98177259
• Report Number: 9611109-2018-00062
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-50
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 12/22/2017; 05/10/2018
• Supplement Dates FDA Received: 03/16/2018; 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1