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

Model Number	60-02-60Z
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the cp5.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.Following a further inspection, the cp5 connection cable to s5 was unplugged and reconnected, the connector did not click into place.After the third attempt the connector clicked securely into place.The cp5 was opened internally and all cables checked: no further deviations were detected.Subsequent functional verification testing (two hours) was completed without issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that a cp5 control panel turned out during procedure and a pump stop occurred.The user switched the cp5 power switch a couple of times to reactivate the cp5 panel.There was no patient injury.
Additional Manufacturer Narrative
Through follow up, livanova was informed the cp5/s5 has been used many times after the failure without any error.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
A device service history review was performed and revealed that the unit was installed in 2022 and no similar events were reported since.Serial read out (real time device parameters and setting recording file) of the pump was collected and no relevant information was identified.Based on the information collected the most likely root cause of the issue is a loose connection between the cp5 connection cable and the s5 console.According to the instruction for use of the cp5 system, the connection cable has to be checked before the use.Therefore, an unintended user error may have led to the reported malfunction.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: CP5
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20619380
• Report Number: 9611109-2024-00522
• Device Sequence Number: 7534710
• Product Code: DWA
• UDI-Device Identifier: 04033817902782
• UDI-Public: (01)04033817902782(11)220922
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2025

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: 60-02-60Z
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 01/20/2025; 03/31/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 02/19/2025; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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