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 Low Oxygen Saturation (2477)

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.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.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a lifesparc controller failed to run the pump and o2 saturation decreased to 60%.The screen went black, an alarm sounded and the system reboot itself but the pump did not run.The device was changed out and the saturation improved.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: the controller was requested for investigation at the manufacturer site.The error condition could be confirmed but not the pump stop.The controller was powered-on and set to operate a pump.After approximately 6 hours of operation, the controller alarmed and the screen displayed a critical error.The pump continued to run when this occurred.The controller was power cycled and the error did not re-occur.The controller was allowed to operate continuously for 6 days.The error condition did not re-occur.It is unclear from the description of the event and subsequent interviews with the customer exactly what sequence of events took place.The controller is designed to keep the pump operating at the set speed in the event of a user interface software failure.If the operator powers off the device, the pump will stop.For this reason it is recommended in the instructions for use that the device not be powered off if this condition occurs.It is not clear if the operator attempted to power cycle the device, which would have stopped the pump.When a critical error occurs, the main lcd display will blank for approximately 20 seconds before the critical error screen is displayed and the controller will generate a continuous alarm tone.Data log review showed an interruption where data logging stopped and the next event was a power on.This is consistent with a software, sbc board, or intermittent power supply failure and the operator power cycling the device.The data log showed the pump operating at 2021/05/08 21:22:34.The data log doesn¿t show another power on until 2021/05/08 23:39:17.It is possible that the operator power cycled the device prior to this and an error condition prevented software from starting and writing to the data log.The device data log showed information which was consistent with the alarm and blank screen failure mode reported by the end user, but not the pump stop.The critical error was reproduced on the returned device, but when this occurred, the pump did not stop or change speed.The controller hardware design is such that the pump drive is independent of the user interface software and display.No single fault was identified which would cause the alarm, blank screen, and pump stop as reported by the site.The controller and dock were damaged due to improper shipping and handling.It is recommended that both be made non-clinical use devices, since improper shipping may have caused damage beyond what was visible upon inspection.Based on the investigation results, the most likely root cause was a failure on the sbc board.In addition, based on the data log analysis it cannot be ruled out that pump stopped due to controller being power cycled by the user.

Manufacturer Narrative

H.10: in a previous supplemental report for this event, submitted on july 28, 2021, an exact root cause for the reported pump stop was not indicated and user error was only suggested as a possible cause.However, after additional internal discussions on this event, it was discovered that a meeting was held between the customer and livanova medical affairs shortly after the event, during which the customer reported that the pump stop occurred because the user shut the controller off before acquiring and setting up the backup controller.This is contrary to the device dfu and confirms that the reported pump stop occurred as a result of user error.No changes to previously identified actions were currently deemed necessary in response to this new information.If any additional information is received regarding this event, it will be filed in a supplemental report.

• 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.; acs.customerquality@livanova.com; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 11899607
• MDR Text Key: 253135731
• Report Number: 2531527-2021-00020
• 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,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5900-0001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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