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

Model Number 5900-0000

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Cardiac Arrest (1762)

Event Date 07/23/2021

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Cardiacassist inc.Manufactures the xlifesparc 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.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report of a low flow alarm on a lifesparc controller during support of a patient started on (b)(6) 2021.The user believed it was due to clot but he was not able to locate or see anything clotting in circuit.Epinephrine was given to the patient and cpr was conducted due to pea.The patient expired.

Manufacturer Narrative

H.10: the controller data log file was reviewed.The data log showed that the pump was operated using controller (b)(6).Data captured during this time indicated that the pump remained stable within allowable tolerance around the set speed of 6600rpm.Near the end time of the case, measured flow, estimated flow, and pump current all decreased while speed remained steady.This is consistent with a restriction in flow occurring outside of the pump.The lifesparc controller is designed to operate the pump at a continuous rotational speed selected by the operator.The controller indicates a measured flow if a flow sensor is connected and an estimated flow otherwise.Measured flow is computed by measuring transit time with an ultrasonic flow sensor clamped to the tubing.Estimated flow is computed based on pump speed and current.At a fixed speed, a higher current indicates greater work performed by the pump and therefore a higher flow.Clot formation on the moving parts of the pump can cause an increase in estimated flow without a corresponding increase in actual flow, since the added mechanical resistance caused by the clot can increase the required current.Clot formation outside of the moving parts of the pump can cause a decrease in actual flow which also appears as a decrease in estimated flow.Through follow up communication it was also reported that the low flow condition was possibly due to clots of unknown location present during support.Based on the above facts and considering the investigation results, a malfunction of the lifesparc controller can be ruled out.The most likely root cause of the event is a clots/throumbus obstruction possibly due to patient condition causing a decreasing flow and resulting in the reported event.

Event Description

See initial report.

• Brand Name: LIFESPARC CONTROLLER
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• MDR Report Key: 12413069
• MDR Text Key: 269505644
• Report Number: 2531527-2021-00031
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K183623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5900-0000
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other