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

Model Number	1286
Medical Device Problem Codes	Pumping Stopped (1503); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient was inpatient and had done a self test right before 8 am.Interrogation noted an alarm showing ¿pump off¿ and ¿low flow.¿ alarm parameters did not look consistent with the pump being off, but the site was concerned.The patient reported to not have felt, heard, or seen anything different during the self test.Following review, log files confirmed a brief (f69) intentional pump stop event at 07:59:39 on 23jul2025.The data indicated that the stop pump button was pressed on the system monitor, resulting in a brief pump stop.At the time of the event, the system controller was connected to the power module.The site stated the nursing staff did not recall pressing the button but could not confirm.
Event or Problem Description
Additional information was provided on 29jul2025 that the pump stop was unintentional and due to user error.There was no impact to patient due to the pump stop and the patient remained in the hospital and would be discharged soon.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event of the pump restarting due to an intentional pump stop was confirmed via review of the submitted log files; however, it could not be conclusively correlated to an issue with the system monitor (serial number: (b)(6)).Review of the submitted log file for the reported event date 23jul2025 revealed an intentional pump stop event.The pump stop was initiated at 07:59:39 and at 7:59:40 the operation mode was changed back from continuous to pulse.The pump was restarted, and by 07:59:41 pump speed was restored to the expected operation value.No other notable events were observed within the submitted log files.No products related to this event returned to abbott for further analysis.Additional information indicates the pump stop was unintentional user error, there was no patient impact as a result of the event, and the patient remains at the hospital due to being implanted earlier in the month.The root cause of the pump restarting was determined to be user error.The device history records were reviewed and the records revealed the system monitor (serial number: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 instructions for use (ifu) section 4 - subsection entitled ¿pump stop button¿ provides step-by-step instructions for utilizing the pump stop button.The user is first instructed to hold the pump stop button for 10 seconds.It is noted that after the countdown is completed, a pump off alarm appears which is accompanied by a continuous audible alarm.The user is then instructed to press the silence alarm button on the system monitor display.Heartmate 3 instructions for use section 5 entitled ¿surgical procedures¿ indicates that the pump will start when the system controller is connected to a driveline, connected to a power source, the backup battery is installed, and any button on the system controller is pressed.Heartmate 3 patient handbook and heartmate 3 instructions for use (ifu) caution 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®, 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: 22682514
• Report Number: 2916596-2025-05106
• Device Sequence Number: 8892244
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2025

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: Lay User/Patient
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 09/25/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/18/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American