MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE TOUCH WIRELESS ADAPTER; VENTRICULAR (ASSIST) BYPASS

Model Number	HMT2100
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer was having issues with connecting the heartmate touch wireless bluetooth adapter.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of issues connecting the heartmate touch wireless adapter, serial number (b)(6), was not confirmed.It was reported that the customer was having issues with connecting the heartmate touch wireless adapter.No product was returned for evaluation.The root cause of the reported event could not be conclusively determined through this analysis.Heartmate 3 instructions for use (ifu) chapter 4 ¿heartmate touch communication system¿ and the heartmate touch communication system quick start guide under ¿how to use the heartmate touch communication system¿ explain the operation of the heartmate touch system, including how to set up the system and connect the tablet to the wireless adapter and system controller, how to determine the status of the wireless adapter, and how to use the heartmate touch app.These documents also warn that the heartmate touch system may be interfered with by other equipment, even if that other equipment complies with cispr emission requirements.Heartmate 3 instructions for use (ifu) chapter 7 ¿alarms and troubleshooting¿ and the heartmate touch communication system quick start guide under ¿troubleshooting guide¿ provide troubleshooting steps to resolve issues related to the heartmate touch, including a frozen screen and the connection failed - heartmate touch app error message.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product, per the device history record review.The wireless adapter is manufactured by a third party who maintains the device history records.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE TOUCH WIRELESS ADAPTER
• 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: 23944794
• Report Number: 2916596-2025-08245
• Device Sequence Number: 21522188
• Product Code: DSQ
• UDI-Device Identifier: 05415067032065
• UDI-Public: (01)05415067032065
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: HMT2100
• Device Catalogue Number: HMT2100
• Device Lot Number: 8244703
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/11/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown