MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, SYSTEM MONITOR; VENTRICULAR (ASSIST) BYPASS

Model Number	1286
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the patient had a low flow and pump stop overnight.It was unclear as to why this happened.There was initial concern that it was due to the system monitor.The event log captured the pump stop that was reported on (b)(6) at 01:08 while using the power module.It appeared that the pump stop button was pressed on the monitor that resulted in the brief 2 second pump stop.The log showed "intentional pump stop." no other unusual events were noted in the log.The patient's left ventricular assist device (lvad) console screen was glitched and the customer was unable to touch the screen without the lvad alarming.The patient switched to battery power and were still flowing on the system controller.The customer unplugged the current console, but it did not resolve the issue.The patient was still inpatient.It was unknown if the system monitor was rebooted before use.No products would be returned.Log files showed that the low flow alarms were secondary to pump being stopped.The patient had no further low flow alarms.The patient was asymptomatic at the time of low flows.The patient did not touch anything on the monitor.
Additional Manufacturer Narrative
Section d4: serial number and primary udi corrected.Section d5: operator of device corrected.Sections h5 and h8: corrected for reusable medical device.Section h6: medical device problem code corrected.Manufacturer's investigation conclusion: the reported event of a pump stop was confirmed via the submitted log files; however, the reported event of the a glitched system monitor screen was not confirmed.The system monitor, serial (b)(6), was not returned for analysis.Data from the reported event date of 12feb2025 in the submitted controller event log file was reviewed.On (b)(6)2025 at 01:08:36 while connected to the power module, there was a brief pump stop that lasted two seconds due to an intentional pump stop.The pump returned above the low-speed limit without issue for the remainder of the log file.There were no notable alarms active in the log file.There were no photos or additional documents provided.Per the provided information, the root cause for the pump stop was unintentionally hitting the intentional pump stop button on the monitor while it was glitched.A root cause for the reported glitched monitor was not conclusively determined through this analysis.Although the system monitor was not returned for evaluation, a corrective and preventative action (capa) was opened to further investigate issues related to the system monitor atypical screen behavior.The device history records were reviewed were reviewed and showed no deviations from manufacturing or qa specifications.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.Heartmate 3 instructions for use section 4-¿system monitor¿ explains how to properly interpret and troubleshoot system monitor communication issues and error messages.Heartmate 3 instructions for use section 4-¿system monitor¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly handle the monitor to prevent damage.The device is included in the system monitor atypical screen behavior advisory issued by abbott on 08 may 2024.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE®, SYSTEM MONITOR
• Common Device Name: 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: 21508103
• Report Number: 2916596-2025-01162
• Device Sequence Number: 4501518
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142(11)200501
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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
• Operator of Device: Health Professional
• Device Model Number: 1286
• Device Catalogue Number: 1286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q224-HF-1
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Hispanic
• Patient Race: White