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

Model Number	48-20-00
Medical Device Problem Code	Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received report of pump motor head malfunction on a cp5 console.The issue occurred during setup and there was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the cp5 console.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not find any issue.During on site visit, customer communicated to the livanova technician that he was not 100% sure that the error code was the one reported to livanova.However, the device was found to be working within specifications.Subsequent functional verification testing was completed without further 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
See initial report.
Additional Manufacturer Narrative
During on-site visit, customer communicated to the livanova technician that he was not 100% sure that the error code was the one reported to livanova.A technical safety inspection was successfully performed: no hardware malfunctions were detected, the units worked as expected and within specification.Therefore, no replacements were carried out and the cp5 system was returned to service.Complaints database analysis revealed no similar event since unit installation in 2022.Based on all the above facts, any hardware malfunction on the equipment can be ruled out as root cause of the event.It cannot be excluded that issues related to the circuit configuration or to the operating conditions.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: CP5 CONSOLE
• Common Device Name: 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: 15673235
• Report Number: 9611109-2022-00545
• Device Sequence Number: 6406960
• Product Code: DWA
• UDI-Device Identifier: 04033817903123
• UDI-Public: (01)04033817903123(11)220331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: 48-20-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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