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

Model Number 106524US

Device Problem Decreased Pump Speed (1500)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that when the history was checked, only 5 events were seen.The day prior, numerous events were noted in the patient history including speed changes.The emergency backup battery (ebb) was exchanged and since then more events were recorded.Log files contained a backup battery fault alarm from (b)(6) 2023 at 00:13 to 08:09.Another backup battery fault alarm was noted on (b)(6) 2023 at 10:15.The alarm resolved quickly.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files did not confirm the reported speed changes.The controller event log file contained approximately 11 hours of events from 13dec2023.The file captured the pump operating at a fixed speed of 6200 revolutions per minute (rpm) with a low speed limit of 5600 rpm.Throughout this file, the actual motor speed ranged from 5700-6300 rpm.No notable events or alarms related to the pump were captured.The pump appeared to function as intended at the fixed speed.It was reported that the hospital was contacted, and responded indicating that no additional information will be provided.The patient remains ongoing on the heartmate (hm) 3 left ventricular assist system (lvas), serial number mlp-020042, with no further events reported at this time.The relevant sections of the device history records for mlp-020042 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate (hm) 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.Section 1, ¿introduction,¿ addresses pump parameters, including pump speed and pulsatility index (pi).Section 1 also notes that the heartmate 3 employs a feature called artificial pulse.Although the clinician will set only a single speed, the rotor speed will periodically depart from this value (2000 rpm above and 2000 rpm below the set speed) in order to contribute a flow disruption that in some ways mimics native cardiac contractility.Section 4, "system monitor", explains that the system monitor displays the pump speed in revolutions per minute (rpm).This value matches the actual speed within ±100 rpm under nominal conditions.It is also noted that pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events and may be initiated for reasons other than true pi events, including sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.If the system detects a pi event, the pump speed automatically drops to the low speed limit and slowly ramps back up at a rate of 100 rpm per second to the fixed speed setpoint.It is also noted that the system monitor displays the pump speed in revolutions per minute (rpm).This value matches the actual speed within ±100 rpm under nominal conditions.The heartmate 3 lvas patient handbook, rev.D is currently available.Section 5 "alarms and troubleshooting" outlines system controller alarms, as well as how to respond to each alarm condition.The handbook cautions patients to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.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 (ASSIST) 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18412937
• MDR Text Key: 331722846
• Report Number: 2916596-2023-08832
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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: Lay User/Patient
• Device Expiration Date: 09/19/2022
• Device Model Number: 106524US
• Device Lot Number: 7312737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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 Sex: Male
• Patient Weight: 111 KG