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

Model Number	1286A
Medical Device Problem Codes	Pumping Stopped (1503); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that log files were submitted due to pump off episode.During operation, thrombectomy from left ventricular cavity was done, left atrial appendage (laa) was closed.In operating room, system controller was programmed as usual; backup battery was installed.After transfer to intensive care unit (icu), approximately 30 min later, pump off alarm shortly appeared with drop of arterial pressure.Implant team came to the icu, and checked on patient condition, pump, system controller and power connections.No technical issues were noted.The patient remained stable.The log file captured on (b)(6) 2025 at 13:31:40, intentional pump stop messages (f69).It appeared to have occurred by the system monitor pump stop command being activated.The pump was stopped for about 2 seconds.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was later reported that the pump stop button was pressed accidentally.The system monitor was operating as expected.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a pump off event associated with the pump stop button being accidentally pressed can be confirmed.Log files provided by the customer were reviewed.The event log file contained data recorded on (b)(6) 2025.The pump was connected to the system controller and the system was intentionally started at the default speed of 3000 rpm (5000 rpm low speed).The clock was synchronized at 10:00:50 and the speed was adjusted to 3500 rpm first and then to 4000 rpm.The low speed was adjusted to 4000 rpm.The pump speed was adjusted to 3500 rpm and then to 3000 rpm.An intentional pump stop command was recorded at 10:04:19, the pump stopped, and the driveline was disconnected at 10:06:06.These events appeared consistent with the process of priming the pump.The pump was connected to the system controller at 11:20:59.The data recorded at 11:32:00 revealed the pump was started, and the speed was adjusted from 3000 rpm to 3400 rpm.The speed was then gradually adjusted to 4400 rpm.The data captured at 13:31:59 revealed an intentional pump stop command.The pump briefly stopped (~ 3 sec) and restarted once the intentional pump stop command cleared.The periodic log file did not contain any data related to the reported event.The system monitor was not returned for evaluation.Per the provided additional information, the system monitor serial number is (b)(6) and the pump stop button was pressed accidentally.The customer also reported that the system monitor was operating as expected.The heartmate 3 instructions for use with system monitor ii, under section 4 system monitor (pump stop button) informs the user how to start or/and stop the pump: use the pump stop button to turn off the pump.To use this feature, press and hold the pump stop button while the pump stop countdown counts down from 10 to 1.The pump stops within the first few seconds of holding down the pump stop button.However, if the button is released before the countdown is complete, the pump resumes at the previously set mode and speed.After the countdown, the stopping pump message appears.The countdown lasts for approximately 10 seconds.The device history records were reviewed and the records revealed the system monitor, serial number (b)(6) was manufactured in accordance with mfg and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE SYSTEM MONITOR II
• 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: 22542410
• Report Number: 2916596-2025-04805
• Device Sequence Number: 7013523
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: (01)00813024010852
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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: 1286A
• Device Catalogue Number: 1286A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 10/28/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/05/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2011
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown