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

Model Number	HMT1100
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the heartmate touch (hmt) was not connecting to any system controller.Troubleshooting was performed, the app was restarted, the ipad was turned off and on, the adapter was unplugged, a new wireless adapter was tried, and the patient cable was changed out.The hmt would still not connect to the system controller.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the heartmate touch not connecting to any system controller was not confirmed as it was not reproduced during testing.The heartmate touch system was connected to multiple test system controllers without issue during testing.The returned heartmate touch tablet was functionally tested with the returned wireless adapter and a test system controller on a mock circulatory loop and was found to operate as intended during analysis.The framework file downloaded from the returned heartmate touch tablet contained data from 14may2024 to 27aug2024.The framework file showed the heartmate touch in use with several system controllers.No atypical events were captured.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.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 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¿ provides troubleshooting steps to resolved various issues while using the heartmate touch, including the system controller not being detected by the heartmate touch app.No further information was provided.The manufacturer is closing the file on this event.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20206249
• Report Number: 2916596-2024-05890
• Device Sequence Number: 7643226
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058(11)240216
• 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
• Report Date (Section B): 11/07/2024

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: HMT1100
• Device Catalogue Number: HMT1100
• Device Lot Number: 10333159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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