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

Model Number	10-95-00
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz roller pump 85.The incident occurred in thailand.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.Testings were carried out by switching pump heads and setting the same occlusion, however the pump still gave error code 2303, while the other pumps did not.In conclusion, whether it is switched or set to lower occlusion, the pump still had issues.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 an essenz roller pump 85 gave the following error message "cpl-b pump defective" (error codes 2303 and 2309) every time the cardioplegia solution was given.There were also other error messages with this involved pump, which found that the pump jerked when it started to rotate.There was no patient injury.
Additional Manufacturer Narrative
H11: livanova determined that error code 2309 does not exist and is likely the result of a typographical error.The reported error code 2303 corresponds to a pump overload condition, which is typically caused by excessive occlusion settings configured by the user.Complaints database analysis revealed no similar event since unit installation in 2024 and no adverse and concerning trends about the reported failure mode have been triggered by periodical complaints statistical analysis.Based on the investigation findings, the issue is considered an isolated event, with the root cause attributed to a defective pump head.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: ESSENZ ROLLER PUMP 85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 22466337
• Report Number: 9611109-2025-90238
• Device Sequence Number: 20856556
• Product Code: DTQ
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)240313
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/29/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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