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

Model Number 60-01-00

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

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).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a centrifugal pump system with tubing clamp displayed an error code during procedure.There was no report of patient injury.

Manufacturer Narrative

H.10:a livanova field service representative was dispatched to the facility to investigate the device and confirmed the issue.The involved drive unit was replaced with a new one and was then investigated.A defective motor control board was found.The part was replaced and the problem solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

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; lindberghstr. 25; munich
• MDR Report Key: 10974119
• MDR Text Key: 220423432
• Report Number: 9611109-2020-00673
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-00
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1