MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE SYSTEM MONITOR; Ventricular (assist) bypass

Model Number	1286
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a - no patient was involved.Section g4: there was no patient involved in this event.The pma# provided is associated with most recent approval.Manufacturer's investigation conclusion: the reported event of the system monitor touch screen not responding was unable to be confirmed.The heartmate system monitor s/n: (b)(6) was not returned for analysis and is still in use.No photos, log files, or additional documents were submitted for review.No patient was involved in the event.The root cause for the reported event was unable to be 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.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate system monitor instructions for use (ifu) informs the user to refer any servicing of heartmate lvas equipment to trained service personnel only.Heartmate 3 instructions for use (ifu) under section 4, entitled ¿system monitor¿, provides an overview of the system monitor and explains how to set up and use it.This section contains troubleshooting steps for the system monitor and instructs the user to contact abbott for assistance if the system monitor still does not work.The heartmate 3 patient handbook and the heartmate 3 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.The device is included in the system monitor atypical screen behavior advisory issued by abbott on 08may2024.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that when the pump speed was set to the lower speed limit at 8000 rpm the system monitor would not work and it could not send information to the pump.If the speed was above 8000 rpm, the device operated as expected.The issue was observed when tested against two different monitors, so it was believed that there was an issue with the power module.The system monitor was removed from service.

• Brand Name: 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: 19991600
• Report Number: 2916596-2024-05088
• Device Sequence Number: 8432416
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1286
• Device Catalogue Number: 1286
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• 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 Sex: Unknown