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

Model Number 106531US

Device Problem Failure to Charge (1085)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

Event Description

Event summary: it was reported that the patient had backup battery fault alarms starting on 18dec2023.It was also noted that the patient experienced an ebb fault alarm in november, covered under cs-191449, which cleared with a self-test.When the alarm occurred on 14jan2024, the patient was sitting at home watching tv.The patient silenced the alarm around 2200 and went to sleep.It was noted that during the day the patient wears a hunting vest and each of the batteries and the system controller have their own pockets.The alarm would not clear with a self-test and went away after 8-12 hours.Log files were submitted for review and confirmed a backup battery fault due to load test failure on 14jan2024.The alarm cleared at 0:47:11 on 15jan2024.It was later reported that the backup battery was reseated in the clinic, the alarm did not reoccur, and the patient would be monitored for further alarms.It was noted that no product would be returning.It was reported on 13feb2024 that the patient presented to the clinic with another backup battery fault alarm that started on 12feb2024.Log files were submitted for review and confirmed backup battery faults on 12feb2024.A system controller exchange was performed on 13feb2024 which resolved the alarm.The patient was sent home in a stable condition.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of backup battery fault alarms was confirmed via analysis of the log files; however, the alarms were not reproduced during testing of the returned system controller.The log files contained approximately 27 days of data combined (10jan2024 ¿ 16jan2024, and 23jan2024 ¿ 13feb2024 per the timestamps).The log files captured backup battery fault alarms from 14jan2024 at 18:25:57 to 15jan2024 at 00:47:11, on 12feb2024 at 14:43:26 and from 14:44:20 to 14:44:29 due to the backup battery not passing the load test.The backup battery did not pass the load tests due to the unloaded voltage measuring below the acceptable threshold, and the loaded voltage measuring under the acceptable threshold compared to unloaded voltage.The alarms resolved each time when additional load tests were performed, and the backup battery passed testing.The alarms did not affect the controller¿s ability to operate the pump at the set speed.The returned system controller (serial number: (b)(6)) passed functional testing and successfully operated in a mock circulatory loop without any issues or atypical alarms produced.During testing, multiple load tests were performed and the controller passed each time without any issues.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the heartmate 3 system controller, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The system controller was shipped to the customer on 30jan2023.Review of the dhr also revealed that the system controller was manufactured with the implementation of corrective and preventative action (capa) 116200, which implements the application of grease on the backup battery ribbon cable.Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (visual and auditory), including the backup battery fault, alarms, and the actions to take if the alarm cannot be resolved.Heartmate 3 instructions for use section 5 ¿ ¿surgical procedures¿, explains how to install the backup battery in the system controller.Additionally, section 2 ¿ ¿system operations¿, explains how to properly replace the backup battery.Heartmate 3 instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment, including the controller.The patient handbook and the instructions for use caution the user 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 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: 18839806
• MDR Text Key: 337796855
• Report Number: 2916596-2024-01028
• 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,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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: 8843963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2022
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 118 KG