MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; Ventricular (assist) bypass

Model Number 106531US

Device Problem Insufficient Information (3190)

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

Event Date 09/17/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of low flow alarms was confirmed based on the information contained in the log files.The event log file retrieved from the returned system controller (b)(6) contained data recorded on (b)(6) 2023 from 12:02 to 21:12 when the system controller was disconnected from the pump.The recorded data revealed normal system operation at the set speed of 5500 rpm with calculated average flow between 3.9-4.6 lpm, calculated pi average between 4.4-8.6, and motor power between 3.8-4.1w when on (b)(6) 2023, at 20:05 the flow suddenly decreased to 1.8 lpm and then to 0 lpm.The decrease in flow showed a corresponding decrease in pump power.The system controller activated a low flow alarm.The speed was adjusted few times, from 5500 rpm to 3000 rpm, from 3000 rpm to 5700 rpm, from 5700 rpm to 4000 rpm and from 4000 rpm to 5700 rpm; however, the low flow alarm associated with 0 lpm flow remained active until the pump was disconnected.The periodic log file contained events recorded from (b)(6) 2023 to (b)(6) 2023.The data captured in the last two recorded entries revealed that the flow recorded at 19:55 on (b)(6) 2023 was 3.9 lpm and the flow captured at 20:55 (last entry) was 0 lpm.The returned system controller, serial number (b)(6) was functionally tested and was found to function as intended.The investigation did not identify a correlation between the low flow events captured in the logfile and the returned system controller.Heartmate 3 patient handbook, rev d, under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use, rev c, under section 7 ¿alarms and troubleshooting¿ explain all alarms and the proper actions to take if the alarms cannot be resolved.Heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, section 4 entitled ¿system monitor¿ explains that the low flow hazard alarm is triggered when pump flow is less than 2.5 lpm, the pump has stopped, the pump is not operating properly, or the driveline is disconnected from the system controller.Changes in patient conditions can result in low flow, such as hypertension.Heartmate 3 patient handbook, rev d, cautions the users 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.The device history records were reviewed and the records revealed the controller was manufactured in accordance with mfg and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had a system controller exchange on (b)(6) 2023.The reason for exchange was not provided.Related mfr #: 2916596-2023-06958 (system controller).Related mfr #: 2916596-2023-07142 (pump).

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• 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: 18916617
• MDR Text Key: 337821921
• Report Number: 2916596-2024-01662
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• 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
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Device Lot Number: 8395629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White