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

Model Number 106531US

Device Problems Alarm Not Visible (1022); Electrical Power Problem (2925)

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

Event Date 01/05/2024

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 the patient had low voltage advisory alarms on (b)(6) 2024.The patient noted that they could not recall that the batteries were running low or that any alarms occurred.Event log files were sent for review.The event log files captured no alarms as the data was overwritten by pulsatility index (pi) events.There were no unusual events captured.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of low voltage alarms was unable to be confirmed.The heartmate 3 system controller (serial number: (b)(6) ) was not returned for analysis; however, a log file was submitted ( (b)(4) ) for review that showed events spanning approximately 17 hours ( (b)(6) 2024 at 16:22:27 ¿ (b)(6) 2024 at 09:59:42 per timestamp).There were no notable alarms active in the log file that would indicate an issue with the system controller.Multiple good faith efforts were sent asking if the low voltage alarms were associated with depleted batteries, if the low voltage alarms activated while the patient was sleeping, if the alarms resolved, and if so how.To date, no response has been provided.A root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed, and the records revealed the heartmate 3 system controller (serial number: (b)(6) ) was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including low voltage alarms.Heartmate 3 instructions for use section 8 entitled ¿caring for the equipment¿ and heartmate 3 patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.Heartmate 3 patient handbook and heartmate 3 instructions for use (ifu) under section 3, entitled ¿powering the system¿, describes the various ways to power the heartmate 3 lvas.These sections explain how to properly switch between power sources.The patient handbook 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® 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: 18693986
• MDR Text Key: 335194046
• Report Number: 2916596-2024-00935
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: (01)00813024013235(17)221003
• 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: 07/15/2024

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: 10/03/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7305507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 07/11/2024
• Supplement Dates FDA Received: 07/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White