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	01/24/2025
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 completed.
Event or Problem Description
It was reported that the patient was on normal ward and it was not possible to connect bluetooth from the ipad.The button from wireless adapter was not on normal position.It was noted that the adapter did not change color.The adapter was exchanged.
Additional Manufacturer Narrative
Section d5: operator of device corrected sections h5 and h8: corrected for reusable device.Manufacturer's investigation conclusion: the reported event of an inability to connect the wireless adapter to the heartmate touch due to an issue with the button was confirmed.Evaluation of the returned adapter revealed that the pairing button was unable to be pressed as it was loose and not pushing on the internal switch button.The pairing button was able to slide freely and become recessed into the adapter when tilted.The wireless adapter was disassembled for further inspection and it was revealed that one of the pins on the switch that the pairing button presses into was detached/lifted from the solder pad due to insufficient solder and the button on the switch was broken off; this prevented the pairing button and internal switch from operating.No other physical anomalies were observed.The reported event was determined to be due to insufficient solder being applied to the component during manufacturing.The wireless adapter is manufactured by an external supplier, and an external corrective action has been implemented to address this issue.The wireless adapter associated with this event (serial number: (b)(6) was manufactured prior to the implementation of the corrective action.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¿ explains the operation of the heartmate touch system, including how to set up the system and connect the tablet to the wireless adapter, how to determine the status of the wireless adapter, and how to use the heartmate touch app.Heartmate 3 instructions for use (ifu) section 8 "equipment storage and care" describe how to care for and clean all equipment.Section f, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvas.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 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: 21369073
• Report Number: 2916596-2025-00655
• Device Sequence Number: 8590426
• Product Code: DSQ
• UDI-Device Identifier: 05415067032065
• UDI-Public: (01)05415067032065(10)7625354
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/16/2025

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: HMT2100
• Device Catalogue Number: HMT2100
• Device Lot Number: 7625354
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2020
• 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: Female
• Patient Weight: 110 KG