MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-60

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in harefield, united kingdom.According to information, a pressure arterial alarm appeared, the pressure on the centrifugal head display went blank some time while the pressure on the main display was working again.According to information, same issue (display went blank for some time and then worked again) occurred also to the cardioplegia display customer has decided to put the pump out of service.A livanova field service engineer was dispatched to the customer facility.Unit was inspected and issue could not be reproduced: the cp5, clamp and drive unit were all functioning correctly.The serial read-out of cp5 have been investigated and the log shows issues with the can connection and the connection from drive unit to the control panel.This problem can be related to electrical connections or electromagnetic compatibility (emc).As a precaution, the processor board hkr was replaced.The unit was finally, firmware upgraded, calibrated, functionally tested.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report that, a cp5 returned autoclamp not opening/closing error although it was opening and closing during a case.The message came up two times and then disappeared for the rest of the case.There is no report of any patient injury.

Manufacturer Narrative

A device service history review has been performed and identified that the unit was manufactured in 2015 and no other similar events have been reported.The serial readout pulled from the cp5 was analyzed and it was found that the issue with the can bus and the issue with the connection between the drive unit and the control were recorded in previous days as well.Despite requested, the logs from all of the roller pumps were not received.The most probable root cause of all the events experienced by the customer were caused by an electromagnetic compatibility issue or bad electrical connections, that resulted in a problem with the can bus communication and a faulty connection from the drive unit to the control panel.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15886720
• MDR Text Key: 307883675
• Report Number: 9611109-2022-00619
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

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: 60-02-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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