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

Model Number 5800-0000

Device Problem Pumping Stopped (1503)

Patient Problem Cardiac Arrest (1762)

Event Date 10/13/2021

Event Type  Death  

Event Description

Livanova received a report that a lifesparc pump was making grinding noise then suddenly stopped.The patient arrested and ultimately expired.Earlier in the morning, it was reported that the lifesparc controller gave a ¿pump current high¿ alarm.Perfusion notified and came bedside to assess.Perfusionist did not see any obvious thrombus in pump but did notice clot in quadrox oxygenator (non livanova product).The oxygenator changed at that time, two hours prior to grinding noise and pump stoppage.

Manufacturer Narrative

Patient information was not provided.Cardiacassist inc.Manufactures the lifesparc system.The incident occurred in (b)(6).Through follow up communication livanova learned that the patient was cannulated on (b)(6) 2021 thus, he was on support for 39 days before the incident occurred which is not in accordance with device instruction for use.The reported event has been medically assessed and result of the assessment is that the noise and pump stop are likely due to thrombus formation.In addition, it was assessed also that replacement of the oxygenator only did not resolve the clot at the pump.Furthermore, as per device instruction for use, the action required by the user in case of "pump current high" alarm is to change the pump and not the oxygenator.The alarm "pump current high" appears when the pump current > 2.60 ampères and indicates that the pump requires more current to spin due to an increasing resistance to its rotation.This situation is compatible with thrombus formation at the level of the pump.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: the involved pump was made available for investigation and the controller data log has been provided for evaluation.A visual inspection of the returned part revealed a buildup of biologic deposit at the pivot bearing between the rotor ruby ball and the upper housing ceramic cup.The grinding noise and high current could not be recreated or confirmed since the device would not start up during return investigation probably due to the large, dark red biologic deposit surrounding the ruby ball-ceramic cup pivot bearing that likely prevented blood from flowing across the bearing.A review of the controller log from the case revealed three time periods of note; first the initial ¿pump current high¿ around midnight on (b)(6) 2021, then a short pump stop around 2:40 am, and, finally, the return of the ¿pump current high¿ alarms and ultimately the pump failure at 4:40 am.A comparison of pump flow, pump speed, and pump current graphs revealed the only discrepancy between the three parameters occurred at midnight on (b)(6) 2021 when current spiked without a similar jump in flow or speed, in line with the initial ¿pump current high¿ alarms.The pump was stopped for approximately five minutes, likely for the oxygenator exchange mentioned in the complaint report.Details on anticoagulation were not provided to livanova.The site exchange of the oxygenator shortly before the end of support suggests that anticoagulation may have been insufficient leading up to (b)(6) 2021, and the temporary pump stoppage, presumably to exchange the oxygenator, may have further exacerbated the deposit formation at the pivot bearing due to blood stagnation.As per lifesparc pump's instruction for use ¿the pump should not be stopped for longer than five minutes without consideration of additional anticoagulation as the risk of thromboembolism is increased after blood has remained stagnant in the pump,¿ against prolonged lack of flow.Additionally, as per the device instruction for use ¿monitor the patient using medically appropriate procedures during the period of extracorporeal blood circulation.During support, the patient¿s activated clotting time (act) should be maintained at approximately 200 seconds to help control the formation of thrombus.¿ finally, the lifesparc controller's instruction for use states that the ¿pump current high¿ alarm can possibly be caused by thrombus formation, and the appropriate action is a pump exchange.The clinical team did not immediately exchange the pump after initial pump current high alarms.In addition, patient was put on support on (b)(6) 2021 and the issue occurred after 39 days without pump exchange therefore exceeding the recommended time frame of device use.Dhr review has not pointed out any deviations or non-conformities possibly relevant to occurred issue and no further similar complaints have been recorded for noticed product lot.Based on the investigation results and considering that the pump worked correctly for 39 days and that clots were noted in the circuit, it cannot be ruled out that the most likely root cause of the reported pump stop is traceable to prolonged device usage in combination with clot/thrombus formation probably caused by the specific anticoagulation therapy.

Event Description

See initial 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.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; pittsburgh, PA 15238
• MDR Report Key: 12804696
• MDR Text Key: 280713225
• Report Number: 2531527-2021-00045
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5800-0000
• Device Catalogue Number: 5800-0000
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male