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 Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2020

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 livanova field service representative was dispatched to the facility to investigate the device and experienced a drive unit error code associated to a discrepancy between the set value and actual value of pump rpm.A loan device was provided to the customer.The affected device has been requested back to the manufacturer site for 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 stopped during priming.There was no patient involvement.

Manufacturer Narrative

H.10: the reported issue could not be confirmed during investigation at the manufacturer site.The device was found to be working within specifications.However, the potentially involved part, such as processor board, motor control board and centrifuge main cable have been replaced as precaution.Since no defects on components could be identified, a temporary loose connection between boards which may have contributed to the reported issue cannot be excluded.

• 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: 10057382
• MDR Text Key: 194047633
• Report Number: 9611109-2020-00306
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• 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: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1