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

Model Number	HMT1100
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nursing staff on the third east ward could not connect the patient via bluetooth.They swapped the equipment trolly to a different system and connected without issue.
Additional Manufacturer Narrative
Section d4: device manufacture date cannot be determined.The primary udi number in d4 is updated with all of the current information available.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Section d4: serial number corrected.Manufacturer's investigation conclusion: the reported event of difficulty establishing bluetooth connection was not confirmed.It was reported that issue was resolved by swapping out the heartmate touch tablet, heartmate touch adapter, and power module.No product was returned for evaluation.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) (rev.B) chapter 4 ¿heartmate touch communication system¿ and the heartmate touch communication system quick start guide (rev.B) 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) (rev.B) chapter 7 ¿alarms and troubleshooting¿ and the heartmate touch communication system quick start guide (rev.B) under ¿troubleshooting¿ cover all alarms (visual and audible), including the connection failed - heartmate touch app error messages, and the actions to take when the alarms occur.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: 20558607
• Report Number: 2916596-2024-06941
• Device Sequence Number: 8996161
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058(11)220404
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2022
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 92 KG