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

Model Number	5800-0000
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report that a lifesparc pump began making noises and stopped during support.The noisy pump was noticed by a family member of the patient and when inspected by a nurse, it was observed that the pump had completely stopped and the controller began alarming.The patient was on support for 10 days at the time of the pump stop.The entire circuit was swapped out and replaced and the issue was resolved.No harm to the patient was reported.
Additional Manufacturer Narrative
H10.Livanova manufactures the lifesparc pump.The incident occurred in the (b)(6).There was no report of patient injury.The customer provided a photo of the pump which appears to show thrombus build up.During follow-up communication with the livanova representative, it was found that during the pump stop event, the lifesparc controller displayed a "pump stopped" error message and the system attempted to restart the pump.The secondary display lights reportedly scrolled quickly for a few seconds before the pump stop occurred.It was reported that the patient was on anticoagulants and the pump is awaiting return.Device evaluation is anticipated but has not yet begun.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10.The pump was returned to livanova for evaluation.A visual inspection was performed which identified a dark red ring of biological deposit on first barb of outlet connector and a dark red mass of biological deposit present around the rotor tip and ceramic cup.The ruby ball was found to be decoupled from inside the ceramic cup circumference.There was also some light wear/scuffing of the impeller vanes, suggests vanes contacted the upper housing inner surface when the pump was running.A functional inspection was attempted.When pump startup was initiated, the device did not pulse and no rotor motion was observed, leading to a failed startup.Further functional testing could not be performed because the device would not start.The noise reported could not be recreated or confirmed because the pump could not start or be functionally tested.However, investigation of the returned product determined that the noise and subsequent pump stop was most likely caused by a buildup of biological deposit at the pivot bearing between the ruby ball and the ceramic cup, as well as buildup on the side of the rotor assembly body.This buildup was confirmed during visual inspection of the device and its components.The patient was reported to be on anticoagulants, but act numbers were not provided.The lifesparc directions for use (cp-pit-7000-0173 rev.8) contains the following statement about the importance of adequate anticoagulation, ¿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.¿ inadequate anticoagulation may have led to thrombus formation as seen throughout the investigated device.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: LIFESPARC SYSTEM
• Common Device Name: PUMP, BLOOD, CARDIOPULMINARY 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: 17252959
• Report Number: 2531527-2023-00015
• Device Sequence Number: 6831048
• Product Code: KFM
• UDI-Device Identifier: 00814112020593
• UDI-Public: (01)00814112020593(17)230827(11)211118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2023
• Device Model Number: 5800-0000
• Device Catalogue 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: 06/07/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 72 KG