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

Model Number 5800-0000

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.The device serial number was not provided.So the expiration date and udi are unknown.As the device sn is unknown, the manufacture date could not be determined.Livanova manufactures the lifesparc pump.The reported event occurred in (b)(6).Through follow-up communication with the livanova representative, it was revealed that the pump stopped providing forward flow to the patient and the controller displayed a low flow alarm with 0.0 lpm of flow during the event.A "pump stop" alarm was not displayed.The livanova representative also reported that the patient was on anticoagulants (heparin) at the time of the event and was not a covid-19 patient.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned (discarded by customer).

Event Description

Livanova received a report that a lifesparc pump experienced low/no flow during a procedure.The controller was switched and the alarm persisted.The patient was weaned from support and was unstable for a short time, but was okay overall and the procedure was completed without support.The customer noted that they believe a clot caused the issue.

Manufacturer Narrative

H.10.Follow-up communication was performed with the customer and livanova medical affairs.The customer provided additional information on the event, stating that the pump flows suddenly increased and then abruptly stopped.The pump was quickly removed after multiple failed attempts to restart and the procedure was completed without further issue.No investigation was performed on the device by the user to understand what might have caused the malfunction before the device was discarded.Possible causes were clot or the inflow cannula being up against the atrial wall, though it was unclear from the user's perspective if either of these situations was the cause.No thrombotic material was identified anywhere else in the patient.Based on details provided by the customer, the livanova medical affairs expert indicated that inflow obstruction is the most likely cause and would provoke this condition.The device behaved according to specification.The pump did not stop, but rather was unable to deliver forward flow.This was most likely a case of user error or a patient-related condition, though an exact root cause could not be determined.A serial number was not provided, so a review of the dhr could not be performed.The device was discarded by the customer and was not available for return to livanova for investigation.No specific corrective action has been deemed necessary at this time.Livanova maintains and documents periodic customer events monitoring in order to evaluate actions for product improvement.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: 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: 15680033
• MDR Text Key: 302492787
• Report Number: 2531527-2022-00045
• 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
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5800-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Male