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

Model Number 5900-0000

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Cardiacassist inc.Manufactures the lifesparc system.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Through follow-up communication livanova learned that the issue occurred on (b)(6), 6 days after the circuit was change on november 23.It was learned that the patient was initially placed on protekduo support on (b)(6) and circuit was changed (b)(6).Reportedly, the ptt was being maintained between 30-40 for duration of support due to patient having persistent bleeding at tracheostomy site and chest tube site.This was per physician discretion due to continued bleeding issues.In addition, livanova learned that the nurse held the pump in his hand and reported no movement/vibration noted.He also examined the pump head visually and stated that no blood was moving through the pump and the impeller was not spinning.He then clamped off circuit and continued supporting the patient with the ventilator.Decision was made by physician to decannulate the patient at that time.The controller was requested for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a lifesparc controller gave alarms during support reportedly associated to low flow issues.The customer expressed that he thinks the pump had stopped and the controller was reading 0 rpms.Reportedly, ls controller never triggered a ¿pump stop¿ alarm and only a ¿low flow¿ alarm was noted.Physician had decided to decannulate patient and maintain ventilator support.After decannulation it was reported the presence of a large clot in distal tip of protek duo cannula.There was no report of patient injury.

Manufacturer Narrative

H.10: the controller was returned to the manufacturer site for investigation.The device was found to be working within specifications.Data log analysis was performed confirming the low flow event.However, the no flow issue could not be confirmed.Indeed, the pump kept running despite low flow issue and it stopped only under user commands by pushing the stop button with consequent pump stop alarms.Based on the investigation results, the device worked within specifications and all pump stop events observed were accompanied by an alarm and were triggered by the operator.Thus, the pump was assumed to be stopped by the user because of a perception issue likely due to the low flow condition attributable to the reported large clot at the cannula which was likely originated by the specific anticoagulation theraphy applied due to persistent bleeding at tracheostomy and chest tube sites as reported in the event description (not device related causes).

Event Description

See initial 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): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich PA 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13091950
• MDR Text Key: 284129403
• Report Number: 2531527-2021-00052
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

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: 5900-0000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/10/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2021
• 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