MAUDE Adverse Event Report: CARDIACASSIST INC. LIFESPARC SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	5900-0001
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova manufactures the lifesparc controller.The incident occurred in the orlando, florida.There was no report of patient injury.The initial report from the customer stated that the error was a book error, however through follow-up communication with the customer and sales rep, it was determined that the reported error was not a book error.The customer reported that a high pitched sound came from the device (controller audible alarm) and the system displayed a "pump stopped" error, which is not how a book error presents.The customer never stopped the pump themselves and they were unable to get pump to restart.The console would not respond to inputs, it just displayed the pump stop message on a dark screen.The patient was reported to be stable throughout the event.The customer indicated that they were able to swap out the controller and continue the case without further issues.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.All tests and inspections were completed with passing results.The device has been returned to livanova for investigation.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received a report that the lifesparc pump stopped running due to an error/alarm during support with a lifesparc controller.There was no report of patient injury.
Additional Manufacturer Narrative
In the initial report, submitted on jan 17, 2023, it was indicated that this was not a watchdog timeout based on the description from the customer available at the time.However, the complained device was returned to livanova for evaluation and review of the data log showed a power on without a preceding power off.This pattern is consistent with a watchdog timeout.Visual inspection of the returned device did not identify any visible damage.The data log showed that the pump was still operating up to the time the watchdog error occurred, at which point it appears the controller was shut down by the user, which stopped the pump.Upon restarting the controller, the customer pressed the "start pump" button but the data log showed the pump current did not increase above 0ma, indicating an open electrical connection to the pump.This open electrical connection issue is unrelated to the initial watchdog error.The open electrical connection could not be reproduced during testing.The pump underwent 8 continuous dates of operation with no deviations.Based on the current level of information and considering similar cases reported from other customers, the most likely root cause of the reported watchdog error is an intermittent failure with the sbc assembly.Livanova initiated a capa (cpan 210012) in order to investigate and address the reported issue.The investigation to identify the root cause of the lifesparc book error can be reviewed as part of the capa file.Book errors do not affect pump functionality and thus there is no impact on patient support/perfusion.In addition, capa-pit-2023-0003 has been initiated to investigate usability of the lifesparc controller in relation to the watchdog error.A root cause could not be determined for the electrical connection issue, as it was not reproduced during functional testing.The most likely causes of this issue are a fault in the pump, a disconnection of the pump from the controller, or a fault in the controller.The investigation found no evidence of a fault in the controller which would result in an open electrical connection to the pump a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.All tests and inspections were completed with passing results.To address the book error issue, a new version of software has been developed.Through field action fa-cp-pit-2022-005, version 1.1.5 of the software was installed on the complained unit.Regarding the electrical connection issue, as the issue could not reproduced, a root cause was not determined and corrective actions were not identified.Livanova maintains and documents periodic customer event monitoring in order to evaluate actions for product improvement.

• Brand Name: LIFESPARC SYSTEM
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 16185434
• Report Number: 2531527-2023-00001
• Device Sequence Number: 2570426
• Product Code: DWA
• UDI-Device Identifier: 00814112020623
• UDI-Public: (01)00814112020623(11)210624
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 5900-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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