MAUDE Adverse Event Report: CARDIACASSIST INC. LIFESPARC SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 5900-0001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 07/23/2023

Event Type  Death  

Event Description

Livanova received a report that a lifesparc controller / dock 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 controller / dock failed and reported the event for due diligence purposes.

Manufacturer Narrative

H10.Livanova manufactures the lifesparc controller.The event occurred in (b)(6), arizona.Through follow-up communication, livanova learned that the hospital team was having unexplained low flow and initially thought the pump stopped.The 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 identified no evidence of a device malfunction.The data log also showed that the pump was running throughout the incident until the controller was powered off by the user.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 data log 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.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.

• Brand Name: LIFESPARC SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: 17591877
• MDR Text Key: 321617901
• Report Number: 2531527-2023-00025
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00814112020623
• UDI-Public: (01)00814112020623(11)200707
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5900-0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• 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
• Patient Outcome(s): Death
• Patient Age: 38 YR
• Patient Sex: Male