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	04/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1.-a6.Patient information not provided.H10.Livanova manufactures the lifesparc controller.The incident occurred in omaha, nebraska.There was no patient impact.The data log for the complained device was provided by the livanova representative.Review of the log confirmed a roughly 2-minute pump stop which occurred coincident with a flow sensor error.This is consistent with the complaint narrative that the flow sensor was moved just prior to the pump stop.During follow-up communication with the facility ccp, it was reported that during troubleshooting, the user noticed that the pump cable was not completely inserted or locked but was running fine.The user pushed the cable in and both heard and felt a click.The device was requested for return, however the customer declined to return based on the finding of the loose pump cable during troubleshooting.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.Based on discussions with the customer, the most likely root cause is that the pump stop occurred when the user was repositioning the flow sensor dur to the pump cable not being fully seated and locked.Improper seating of the cable can cause intermittent connectivity and result in a pump stop.No specific corrective actions have been identified for this issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3: customer elected to not return device.
Event or Problem Description
Livanova received report that a lifesparc controller experienced a pump stop during patient support and the screen displayed a red banner for stoppage and no led lights were lit.Prior to the event the patient was ambulated, the staff was doing routine checks and moved the flow sensor.The patient lost hemodynamic support and the user attempted to restart the pump which was unsuccessful on the first attempt.They tried a second time and the pump restarted successfully.Patient support continued and no patient harm was reported.

• 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: 16979910
• Report Number: 2531527-2023-00010
• Device Sequence Number: 6480573
• Product Code: DWA
• UDI-Device Identifier: 00814112020623
• UDI-Public: (01)00814112020623(11)210624
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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?: No
• 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: 04/23/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown