MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problems Electro-Static Discharge (2149); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/06/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .

Event Description

It was reported that the patient heard a grumbling noise in their chest on (b)(6) 2022 after standing up from their couch.At that time, the patient had a low flow alarm that was noted to be ten seconds long.The alarm resolved after ten seconds and did not return.Log file analysis revealed pump stops on (b)(6) 2022.The pump stops appeared to be caused by electrostatic discharge (esd) events.The pump restarted as intended.The grumbling noise coincided with the suspected esd events.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the patient¿s submitted log file confirmed pump reset events which appeared consistent with electrostatic discharge (esd) events.The reported low flow alarms on (b)(6) 2022 could not be confirmed through this evaluation as the submitted log files did not capture the event; however, the account attributed the alarms to esd events.The controller event log file contained data from (b)(6) 2022 to (b)(6) 2022.Five pump reset events which appeared consistent with esd events were captured on (b)(6) 2022 at 01:48:43, (b)(6) 2022 at 02:36:41, (b)(6) 2022 at 07:32:42, (b)(6) 2022 at 07:29:09, and (b)(6) 2022 at 08:34:09, which is in accordance with the intended design of the device.Before and after each pump reset event, the pump operated as intended at the set speed.The reported low flow alarm could not be confirmed through evaluation of the submitted log file as the submitted log files did not capture the event.The patient remains ongoing with heartmate 3 left ventricular assist system (lvas), serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Heartmate 3 lvas instructions for use (ifu) section 6 entitled ¿patient care and management¿ explains that strong static discharges should be avoided.Section 7 entitled ¿alarms and troubleshooting¿ explains all system alarms and the recommended actions associated with them.Electrostatic discharge is included in the ¿safety testing and classification¿ tables of this document.Section 1 ¿introduction¿ lists adverse events that may be associated with the use of heartmate 3 lvas and provides an explanation of all pump parameters, including flow.This section explains that pump flow is a calculated value that is estimated based on pump power.Section 4 ¿system monitor¿ provides information about the pump flow display and the low flow hazard alarm condition.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 liters per minute (lpm) and explains that changes in patient conditions can result in low flow.Heartmate 3 lvas patient handbook section 1 entitled ¿introduction¿ warns not to touch the television or computer screen, and not to vacuum or engage in activities that create static electricity.This section also explains that a strong electric shock can damage electrical parts of the system and cause the pump to stop.Electrostatic discharge is included in the ¿safety testing and classification¿ tables of this document.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13652379
• MDR Text Key: 289279374
• Report Number: 2916596-2022-00974
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/09/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7480866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2020
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White