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

Device Problem Infusion or Flow Problem (2964)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Death (1802)

Event Date 05/13/2020

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Cardiacassist inc.Manufactures the lifesparc system.The incident occurred in milwaukee, wisconsin.Investigation results revealed that the reported sound occurs under normal operation and that it did not impact the pump functionality.The first pump was found to be fully functional.The controller log file have been analyzed and a peak current of 2.1 a was noted, which was at the maximum pump speed in saline with no in line restriction.This is a normal current draw level under this condition and confirmed to be within specification.In addition, the reported flow values discrepancy was due to the fact that flow estimator algorithm is configured for blood and not for saline and that is why the estimates are not accurate in priming with saline.As anticipated, the second pump was discarded.However, the controller log showed the pump functioning normally until 1 a.M.On (b)(6) 2020.From 1:00 to 1:30, flow fluctuations without pump speed change were registered indicating that something was happening along the circuit.This occurred again around 4:00 a.M.And continued until a low flow alarm sounded at 5:52 a.M.At this time, the staff responded to the alarm and speed was changed but the flow did not recover and the patient expired.The flow irregularities may indicate a change in patient condition several hours prior to the staff intervention following to the low flow alarm.The flow fluctuations could be due to a volume status change or tamponade or to the pneumothorax procedure.It is not possible to determine this based on the available information.In conclusion, there is no information in the pump log indicating a device malfunction.

Event Description

On (b)(6) 2020 a patient was being prepared to be put on support with a life sparc pump and controller.This was the first use of the system at this hospital.During priming, a whining sound was heard and pump current was reported to be high (2.3.A).Additionally, the difference between measured and estimated saline flow was 3 lpm.Since this was the first case with lifesparc equipment, the staff had no other experiences for comparison and they opted to swap to a second lifesparc pump for patient support which serial number is unknown.The second pump was primed and support continued through the night into the following morning without problems.On (b)(6) 2020 the staff responded to a low flow alarm.Volume was given to the patient and a chest tube was placed to treat a pneumothorax.Upon placement of the chest tube, the circuit filled with air.The patient subsequently expired.The second pump was not made available for return since it was discarded.The first pump and the controller were returned to the manufacturer site for investigation.

• 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: 10133636
• MDR Text Key: 194497133
• Report Number: 2531527-2020-00019
• 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
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death