MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH CP5 DRIVE UNIT; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	60-01-04
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in italy.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issues.Additional anti-disturbance ferrites mounted, functional verification testing completed without issues and serial read-out (real time device parameters and setting recording file) of all the pumps pulled out to be analyzed.The unit was returned to service.Moreover, it was learned that the customer owns equalization cable, even if it is not used often.Livanova initiated an investigation.
Event or Problem Description
Livanova deutschland received a report that during priming a centrifugal pump 5 (cp5) turned off and then back on by itself, at least two times, and an error message on s5 console control panel appeared indicating a temporary internal failure of the centrifugal pump.The customer subsequently turned the entire s5 console off and on again without creating any other problems during the surgery.It was claimed by the customer that also pressure module was defective.There was no patient injury.
Additional Manufacturer Narrative
A device service history review has been performed and identified that the unit was manufactured in 2021 and no other similar event has been reported no concerning trend has been identified.To investigate the issue the serial read-out (real time device parameters and setting recording file) of cp5 drive unit were gathered and analyzed highlighting that a watchdog occurred due to a can bus interruption.Cp5 timeout occurs when the can communication of cp5 or clamp was disturbed and/or interrupted and can be due to external interference from high frequency devices or a can interface malfunction.Without log of all activated pumps an emc issue cannot be confirmed and in general without log files the exact cause for the timeout cannot be detected.Based on all the above, the most likely root causes for the reported event are: external interference from high frequency devices temporary can interface malfunction.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: CP5 DRIVE UNIT
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 19541733
• Report Number: 9611109-2024-00255
• Device Sequence Number: 15373835
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)210415
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: 60-01-04
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown