MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® 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	03/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the system monitor not displaying system parameters was unable to be confirmed.No images were submitted by the account and the system monitor was not returned for evaluation.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 root cause of the reported event could not be conclusively determined through this analysis.The device is included in the system monitor atypical screen behavior advisory issued by abbott.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product, per the device history record review.Heartmate 3 instructions for use (ifu) (rev.C) section 4-¿system monitor¿ explains how to properly interpret and troubleshoot system monitor communication issues and error messages.Heartmate system monitor ifu (rev.E) informs the user to refer any servicing of heartmate lvas equipment to trained service personnel only.Heartmate 3 ifu (rev.C) 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 (rev.D) cautions 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.
Event or Problem Description
It was reported that the pump parameters were not displaying on the system monitor.The patient was connected to the system monitor, but the monitor was not registering that the left ventricular assist device (lvad) was connected, and the clinician was unable to complete interrogation.

• 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: 20407838
• Report Number: 2916596-2024-06467
• Device Sequence Number: 20462591
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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?: 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: 09/19/2024
• Initial Report FDA Received Date: 10/09/2024
• 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
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White