MAUDE Adverse Event Report: CARDIACASSIST INC. LIFESPARC SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 5900-0001

Device Problem Pumping Stopped (1503)

Patient Problem Cardiac Arrest (1762)

Event Date 12/12/2021

Event Type  Injury  

Event Description

Livanova received report that a patient went into cardiac arrest, cpr was administered along with one dose of epinephrine and patient rescued.Reportedly, a critical failure book error was experienced on lifesparc system.Controller was turned off and then rebooted which cleared the error.Patient support resumed.A controller change out was executed.

Manufacturer Narrative

Cardiacassist inc.Manufactures the lifesparc system.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Through follow-up communication livanova learned that the description of this complaint was made on the memory of the nurse who was treating this patient.Her memory was vague and unclear due to the nature of the emergency and the fact that it appears she did not understand what was happening with the book error.She admitted to panicking over the fact that the patient went into cardiac arrest and with the alarm being persistent.However, the lifesparc system is designed in a way that in case of book error which is a software error, the pump continues to run thus the pump did not stop due to this error.There is no way to know for sure the state of the pump when the software error occurred.The controller is designed and has been tested in design verification to demonstrate that a software failure cannot stop the pump without the operator pressing the pump button.It is clear from the controller data log that the pump was stopped by the user that turned off and then back on the controller.The controller restart is not in accordance with device instruction for use which recommends controller replacement and not power cycle since this would stop the pump.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: the affected device was returned to the manufacturer site for investigation.The book error failure could not be reproduced on the returned device.When the device was powered on it appears to function normally and continued to operate for 20 days with no error condition occurring.Additional testing was performed to write to the entire flash memory while running the device application to determine if a flash memory defect was present which would delay the response of software.This test was repeated continuously over 7 days with no watchdog timeout occurring.A critical error condition was deliberately induced by stopping the application software.It was confirmed when this was done that the pump continued to operate and the pump speed as indicated by the speed leds did not change.Thus, investigation results confirmed what anticipated in the initial report and that the reported event was solely due to user voluntary switching off the controller during book error which is not accordance with instruction for use.

• Brand Name: LIFESPARC SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 13203321
• MDR Text Key: 283475382
• Report Number: 2531527-2022-00001
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5900-0001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1