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

Model Number DEMO-LS01

Device Problems Battery Problem (2885); Noise, Audible (3273); Intermittent Loss of Power (4016)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Initial reporter name and address: this was a demo unit.There was no patient involvement and the complaint was filed by the livanova representative who experienced the issue, not by a healthcare facility.Livanova manufactures the lifesparc controller.The event occurred on a demo unit owned by a livanova representative and not tied to a specific facility.Through follow-up communication with the livanova representative, it was found that this unit was stored in a temperature controlled environment when not in use and whenever transported, was done so in the appropriate case.The reported event occurred on multiple occasions during a demo for a customer, both with and without a pump attached.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that a lifesparc controller used for demo purposes experienced unexpected power loss at random intervals and produced a rattling noise.In addition, the batteries were stuck in the device.There was no patient involvement.

Manufacturer Narrative

H.3.Yes.H.10.The complained device was returned to livanova for further investigation.Visual inspection of the returned device found that the plastic enclosure parts were generally in good condition, with no structural damage and minor paint chips and scratches.Two (2) broken battery tabs were observed and the controller battery retainer was found to be missing.The batteries installed were the older 1000-0765 design.New product currently ships with the 1000-1136 battery pack which has a reinforced battery removal tab.Additionally, the batteries installed in this demo device were batteries which had been used previously in engineering for design verification and had been subjected to numerous installation/removal cycles before being used in this demo device.The rattling noise reported on the complaint was reproduced.Sound was consistent with a loose component in the controller enclosure.When disassembled, one of the lock nuts used to secure the chassis assembly components was found to be moving loose within the enclosure.Loose metal parts in the controller enclosure can cause a loss of power by shorting power management components on the main circuit board assembly.It is likely that this loose lock nut was the source of the rattling noise and also possible that it was the cause of the reported loss of power.Additionally, this device appeared to have been subjected to a level of vibration in shipping.As a demo device, this controller/dock would experience a much greater number of shipment cycles than a typical device.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The reported issue was confirmed.The random power shut offs and rattling noise were found to be caused by loose metal parts in the controller enclosure, and the batteries were stuck due to two broken battery tabs (old battery tab design) and a missing battery retainer.

• 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 ; 2812287200
• MDR Report Key: 15245505
• MDR Text Key: 305057591
• Report Number: 2531527-2022-00038
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00814112020623
• UDI-Public: (01)00814112020623(11)200210
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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: Other
• Device Model Number: DEMO-LS01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2020
• 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