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

Model Number 5900-0001

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

A1.-a6.Patient information was not provided.H10.Livanova manufactures the lifesparc controller.The incident occurred in lima, ohio.There was no patient impact.Based on the details provided by the customer regarding the event and following investigation of the device inspecting usage, crack size, location, etc., it was deemed that the cause of the damage was the device falling from significant height when the iv pole that it was attached to was knocked over.The case is inspected for cracks prior to assembly and would not have been released with visible cracks.During final inspection of the lifesparc controller (cp-pit-ip-00138) the procedure states: ¿7.0.Check the controller front/back and dock lower/upper/battery box for panel gaps and cracks.Verify that no openings between panel edges are present which provide a path to the internal compartment of the controller or dock.If visual inspection indicates a possible gap, check with a 0.01¿ to 0.02¿ feeler gauge.Perform this test with the controller and dock disconnected from ac power and with no batteries installed.¿ review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.To address the issue, the cracked case and other damaged components will be replaced during service.Livanova initiated a capa (capa-pit-2023-0006) in order to investigate and address case cracking.The investigation to further identify the root cause and corrective actions for lifesparc case cracks will be included as part of the capa file.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

During receiving of a lifesparc controller returned to livanova for preventative maintenance, a large hole was identified across the bottom of the controller through the front enclosure where the pump and flow connectors reside.The unit was packaged correctly in and there was no damage to the packaging, suggesting the damage occurred at the customer site.During follow-up communication with a livanova representative, it was revealed that the pole the controller was attached to was knocked over and it hit the floor during use on a patient.A backup controller was brought in and connected.No issues were reported after the switch.The nurse present during the case reported that the pump did not stop.No patient harm to patient was reported.

Manufacturer Narrative

H10.To address the issue, it was originally planned to replace the cracked case and other damaged components during service.However, following disassembly of the lifesparc controller and additional evaluation of the extent of internal damage, it was determined to be excessive and the decision was made to fully replace the controller.

• 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): CARDIAC ASSIST INC.; 620 alpha dr.; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha dr.; pittsburgh, PA 15238
• MDR Report Key: 17773199
• MDR Text Key: 323722800
• Report Number: 2531527-2023-00028
• Device Sequence Number: 1
• Product Code: DWA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

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
• 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
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1