MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ROLLER PUMP 85 - ESSENZ; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-95-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received report that, during a procedure, the cardioplegia roller pump 85 no longer worked.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the roller pump 85.Through follow up, livanova was informed that alarm was displayed in red during priming.The pump stopped turning.The pump could not be started and no rpm was displayed on the cockpit, only dashes.No test was done to verify if the pump remained controllable via the backup control panel (ccu).The device was restarted and this solved the issue.Serial read out (real time device parameters and setting recording file) of the pump was collected 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
H11: the cockpit logs were analyzed and confirmed that the error message "cu (control unit) cpl (cardioplegia)-b" defect associated with the error code 4462 was displayed on the cockpit making the user aware of the issue.The 4462 error code indicates that the ccu2 (control unit of the backup control unit 2 associated with the cpl-b pump) was lost for 7 seconds.Complaints database analysis revealed no similar event since unit installation in 2023 and no adverse and concerning trends about the reported failure mode have been triggered by periodical complaints statistical analysis.Based on the current level of information and considering that the issue never reoccurred, it cannot be ruled out that the most likely root causes are the following based on software exceptions: ccu2 was working fine without any defect on the screen and no black screen scenario but does not send ¿livetick¿ can message.False alarm coming from cockpit (wrong monitoring of cu can messages leading to wrong assumption on missing cu).

• Brand Name: ROLLER PUMP 85 - ESSENZ
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21411424
• Report Number: 9611109-2025-00058
• Device Sequence Number: 9518626
• Product Code: DTQ
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)231020
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K232291
• 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
• Report Date (Section B): 04/10/2025

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: 10-95-00
• Was Device Available for Evaluation?: Yes
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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