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

Catalog Number 5800-0000

Device Problem Pumping Stopped (1503)

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

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

Livanova manufactures the lifesparc pump.The reported event occurred in (b)(4), new mexico.There was no patient involvement.As is typically the case with demo units, the involved pump was used during numerous other trainings using saline solution.The pump was never intended to be used on a patient and the pump was plugged and unplugged multiple times during the training.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that a lifesparc pump experienced a pump stop during a training exercise.This was a "demo" pump only and was not being used on a patient.The facility used this pump to practice priming the circuit.

Manufacturer Narrative

During follow-up communication with the livanova service team, it was found that this demo unit (like all demo lifesparc devices) is not a production equivalent device and was intended to be used as-is for non-clinical purposes.Demo units are not used, serviced, or documented using the same standards and practices of a production device, and as such, failures are expected.Additionally, all demo lifesparc pumps are only classified as demo following functional testing failure(s) during production.As the complained unit was a demo unit which failed functional testing during production and was not expected to perform correctly, and is only used for non-clinical purposes in accordance with its label, this event has been reevaluated as a non-complaint and has been determined to no longer be a reportable event.No further investigation is planned and additional information is not expected for this event.

• 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 ; 4129637770
• MDR Report Key: 16199878
• MDR Text Key: 308943159
• Report Number: 2531527-2023-00002
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/19/2022
• 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: Reuse
• Patient Sequence Number: 1