MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ DOUBLE ROLLER HEAD PUMP; 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	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the essenz double roller head pump.The incident occurred in (b)(6).Livanova initiated an investigation.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 double roller pump gave an error message ('pump defective') and would not turn when started during procedure.Not response even when operated after several attempts.Therefore, pump was swapped out with a loaner one by the customer.There was no patient injury.
Additional Manufacturer Narrative
H11: the affected part was returned to livanova for a detailed investigation.The unit has been connected to essenz hlm console test bench and a 24 hour-long test run has been performed.The reported issue was not reproduced.No deviation has been found during test: the pump was able to run smoothly without showing any error message or stop.In addition, despite several attempts, no log files have been provided, thus the error code associated to the error message remained unknown.Complaints database analysis revealed no similar event since unit installation in 2023.Nevertheless, based on the results of a similar complaints review and taking into consideration that the problem was reproduced neither by the field service engineer nor during the investigation, it cannot be excluded that the error code associated was 2329 and that the pump would not start since the error message was not acknowledged.The reported error code is associated with a software exception for which an anomaly was logged.As consequence, software modification will be introduced in software essenz hlm version 1.5 by distinguishing alarm for difference root causes and introducing improved diagnostic information in log files,.
Event or Problem Description
See initial report.

• Brand Name: ESSENZ DOUBLE ROLLER HEAD PUMP
• 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: 19928099
• Report Number: 9611109-2024-00352
• Device Sequence Number: 8141157
• Product Code: DTQ
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)230808
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: 10-95-00
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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