MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106531US

Device Problems Pumping Stopped (1503); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/27/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when the patient was in clinic, they noted pump off on or around on (b)(6) 2024.The patient reported that they were asymptomatic and heard no alarms at the time.Log file review was requested, and both the periodic and event log files captured controller clock corrupt events.The log file captured 1 pump stop, and the amount of time the pump was off could not be determined.Once power was restored, the pump returned to operating at the set speed.Technical services noted that the last good time stamp in the event log file was on (b)(6) 2024 at 7:38:32, and the last good time stamp in the periodic log file was on (b) (6)2024 at 7:12:54.The power loss was noted to have occurred roughly 6 days prior.It was recommended to perform a system controller self-test to verify controller¿s audible alarm¿s function.The patient was also noted to be sleeping on battery power which was not recommended.It was additionally communicated on (b)(6) 2024 that the cause of the controller clock corrupt alarm was due to the patient falling asleep while using battery power.The patient stated that they woke up to dead 14v and 11v batteries.The pump was off for an undetermined amount of time.The patient switched to charged batteries and reported no issues, symptoms, and stated they did not hear the alarms.No issues with the controllers audible alarm function were confirmed, as the site stated the self-test was performed and all lights and alarms were working.The clock was reset on the controller.

• 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: 18746737
• MDR Text Key: 336074797
• Report Number: 2916596-2024-00815
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/26/2022
• Device Model Number: 106531US
• Device Lot Number: 6957802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 120 KG