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

Model Number 60-02-15

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported event.He traced the failure back to a defective processor board.He replaced the part and the issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The root cause of the event has been identified as a defective cpu board.

Event Description

Livanova received a report that a centrifugal pump system with tubing clamp displayed an error code associated to a processor error during a procedure and all buttons on the control panel were not working.There was no report of patient injury.

Manufacturer Narrative

H10: through follow-up communication livanova learned that the user hand-cranked the pump until the control panel was quickly replaced with another and the procedure could be completed without further issues.In addition the correct date of the event was (b)(6) 2020.It has been corrected in the dedicated section b3.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9963141
• MDR Text Key: 195923910
• Report Number: 9611109-2020-00258
• 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
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-15
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1