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

Model Number	49-00-10
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: livanova deutschland manufactures the essenz hlm.The incident occurred in japan.During follow up with customer livanova received the confirmation the occlusion was verified many times.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, during a procedure, the essenz roller pump 85, used for cardioplegia delivery, generates heat and stops.The issue occurred even if the occlusion was modified.There was no report of any patient injury.
Additional Manufacturer Narrative
The sn of the complained roller pump was provided.The occlusion of the pump was verified and no issue was found.Livanova field service has run a (using 1/4 x 1/16 tubing filled with water) at the same occlusion as set by the customer, and no abnormal heat generation was observed.When result of the simulation have been shared with the customer, customer indicated there was a clear increase in heat generation compared to the alternative pump he was currently using.Therefore the customer wants to replace it with a new pump.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 intial report.
Additional Manufacturer Narrative
The cockpit log files have been requested and analyzed.Files were found to be empty, thus further analysis cannot be performed.Complaints database analysis revealed no similar events reported from other customers since the lcr and no adverse and concerning trends about the reported failure mode have been triggered by periodical complaints statistical analysis.Based on the above, the root cause of the event cannot be determined.However, based on livanova knowledge and considering that the design of the essenz pump is the same of the s5 pump, the most likely root cause of the event too high setting for the occlusion of the tubings in combinatin with prolonged use at maximum speed.No other action is deemed necessary.The risk is in the acceptable region.Livanova maintains and documents periodic customer events monitoring process to evaluate actions for products improvement.Livanova will keep monitoring the market.

• Brand Name: ROLLER PUMP 85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18939212
• Report Number: 9611109-2024-00141
• Device Sequence Number: 12523358
• Product Code: DTQ
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)231102
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/11/2024

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: 49-00-10
• Device Catalogue 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: 02/19/2024
• Supplement Date Received by Manufacturer: 05/29/2024; 06/14/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 06/25/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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