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

Model Number	5800-0000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	07/23/2023
Type of Reportable Event	Death
Event or Problem Description
Livanova received a report that a lifesparc pump experienced low flow during support of a patient following a motor vehicle accident.The patient was reported to have a pericardial contusion with bilateral femurs broken and was intubated but was not achieving oxygen saturation despite max vent setting.About 3 hours later, the patient started to experience low flow.The nurse reported that they were giving a large amount of fluid yet were unable to improve the flow and it eventually dropped to less than 1.0 lpm.The team performed an emergent surgery to open the abdominal cavity and pressures were reportedly greater than 500mmhg.Prior to this procedure, the lifesparc circuit was clamped off due to low flow.Soon after the procedure the patient lost pressure and died.The ecmo coordinators reported that they did not feel as if the lifesparc pump failed and reported the event for due diligence purposes.
Additional Manufacturer Narrative
A1., a4.-a6.Patient identifier, weight, ethnicity and race were not provided.D4.Device serial/lot number was not provided, so device expiration date and udi number could not be determined.H4.As the serial/lot number was not provided, device manufacture date could not be determined.H10.Livanova manufactures the lifesparc pump.The event occurred in (b)(6).Through follow-up communication, livanova learned that the hospital team was having unexplained low flow and initially thought the pump stopped.The pump controller banner was reportedly red during the event.However, after discussing over the phone, it was agreed that the pump did not stop and instead experienced a low flow event.The livanova representative believes the customer had a volume issue, as that is what it sounded like clinically.This was further supported through communication with the livanova medical affairs expert, who noted that both the blood loss and low flow reported by the user were likely tied to abdominal compartment syndrome or retroperitoneal bleed based on the patient condition.The data log from the lifesparc controller was sent to livanova for investigation.A review of the data log showed that the pump was running throughout the incident until the controller was powered off manually by the user.At this time, there is no evidence that a malfunction of the lifesparc pump occurred or that a device malfunction contributed to the patient adverse event.Additionally, the customer reportedly does not believe a pump failure occurred and has not identified a specific malfunction of the device.An evaluation of the pump is anticipated, but has not yet been completed.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
D4.Sn: 00876946 expiration date: feb 19, 2025 udi: (b)(4).H4.April 11, 2023 h10.The complained lifesparc pump was preserved and returned for evaluation.The pump was received with the power cord cut.A visual inspection found that the upper housing, lower housing, ruby and impeller vanes all appeared normal.The rotor axial load was measured to determine the upward force with which the ruby ball was being pushed into the ceramic cup.A load measurement fixture was placed on the pump with a central shaft touching the rotor tip and the force necessary to push the rotor tip out of the ceramic cup was measured several times and was not found to be significantly greater than a normal axial load.The device was sectioned for further inspection.After sectioning, the rotor assembly was thoroughly decontaminated and measured with a granite plate.All dimensions were within specifications.Due to the power cord being cut at the user facility, the pump could not be run and functional testing was not possible.No other analyses yielded potential indicators of a pump failure.Review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.All tests and inspections were completed with passing results.As the device evaluation showed no evidence of a malfunction and the customer also does not believe a malfunction occurred, no specific root cause was determined and corrective actions were not identified.Because no malfunction is known to have occurred, no further investigation is required.Livanova maintains and documents periodic customer event monitoring in order to evaluate actions for product improvement.

• Brand Name: LIFESPARC SYSTEM
• Common Device Name: 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: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 17596645
• Report Number: 2531527-2023-00026
• Device Sequence Number: 17997466
• Product Code: KFM
• UDI-Device Identifier: 00814112020609
• UDI-Public: (01)00814112020609(11)230411(17)250219
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2025
• Device Model Number: 5800-0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 38 YR
• Patient Sex: Male