MAUDE Adverse Event Report: Thoratec Corporation HeartMate Touch¿; Ventricular (Assist) Bypass

Model Number	HMT1100
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of a heartmate 3 system in the operating room, communication with the system was lost after the pump had been primed and while the team was attempting to turn it off.The red line never completed across the screen and the pump started back up.Troubleshooting was performed, including disconnecting the bluetooth adapter, rebooting the adapter, and attempting to reconnect the system.Communication was temporarily restored; however, the connection was lost again during a subsequent priming attempt.The entire system cart, including the power module, hm touch ipad, patient cable, and bluetooth adapter, was sent to biomedical engineering team for evaluation.The equipment reportedly passed testing and was returned for clinical use.However, after being connected to a patient in the intensive care unit, communication was again lost after approximately five minutes of operation.
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• Brand Name: HeartMate Touch¿
• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50915584
• Report Number: 2916596-2026-2919774
• Device Sequence Number: 5999067
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: 05415067032058
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: Health Professional
• Device Model Number: HMT1100
• Device Catalogue Number: HMT1100
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown