MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, POWER MODULE PATIENT CABLE 14V; VENTRICULAR (ASSIST) BYPASS

Model Number	103426
Medical Device Problem Codes	Failure to Interrogate (1332); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer was having trouble making bluetooth connection to their heartmate touch (hmt) units while in their supply room with the door closed.The hmts would only intermittently connect when the equipment door was shut but would connect once open.The screen would show a white wheel spinning while bluetooth adaptors attempted connection but would not complete connection.It was later reported that bluetooth connection seemed to be successful, however there were issues with both devices dropping mid connection without a rhyme or reason.It was reported that the final resolution was the data cord from the hmt to the ventricular assist device (vad) was damaged.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
H5 - labeled for single use?: correction.H8 - usage of device: correction.Manufacturer's investigation conclusion: the reported event of losses of connection to the heartmate touch app was not confirmed.Additional information provided stated that the losses of connection were due to a damaged power module patient cable.No product was returned for evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event (including if the patient cable would be returned for evaluation); however, no response was received.The root cause of the reported event could not be conclusively determined through this analysis.Device history records could not be reviewed as the lot number of the product is unknown.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¿ cover all alarms (visual and audible), including the connection failed - heartmate touch app and the disconnected system controller - heartmate touch app messages, and the actions to take when the alarms occur.Heartmate 3 patient handbook section 6 "caring for the equipment" and heartmate 3 instructions for use (ifu) section 8 "equipment storage and care" describe how to care for and clean all equipment.Heartmate 3 patient handbook section 10 and heartmate 3 instructions for use (ifu) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad.This section also informs the user to replace any equipment or system component that appears damaged or worn.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE®, POWER MODULE PATIENT CABLE 14V
• 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: 20527822
• Report Number: 2916596-2024-06914
• Device Sequence Number: 8119618
• Product Code: DSQ
• UDI-Device Identifier: 00813024010784
• UDI-Public: (01)00813024010784
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 10/28/2024

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: Lay User/Patient
• Device Model Number: 103426
• Device Catalogue Number: 103426
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 10/28/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown