MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE TOUCH WIRELESS ADAPTER; VENTRICULAR (ASSISST) BYPASS

Model Number	HMT2100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the heartmate touch wireless adapter not working properly was confirmed.Evaluation of the returned wireless adapter (serial number: (b)(4)) revealed that the pairing button was not functional due to an internal component becoming detached from the printed circuit board (pcb).The wireless adapter is manufactured by an external supplier; therefore, an external corrective action request (ecar) was initiated to further investigate the reported event.The ecar revealed that the root cause of the component becoming detached was insufficient solder being applied to the component during manufacturing.An additional step to perform hand soldering so that sufficient solder is applied was added to the manufacturing process.Furthermore, multiple additional inspection steps were added to the manufacturing process to verify proper solder connections of this component to the pcb.Heartmate 3 instructions for use (ifu) (rev.B) 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) (rev.B) 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.Device history records were reviewed by the supplier via the manufacturing analysis task.Heartmate touch bluetooth adaptor with sn # (b)(4) failed at aoi top side for switch (sw2) misalignment.The misaligned switch (sw2) was reworked and did pass supplier final inspection and final functional test.Refer to the manufacturing analysis task for the device history records reports.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the pairing button on the heartmate touch bluetooth adaptor was not working properly.The item was new and believed to be under warranty.

• Brand Name: HEARTMATE TOUCH WIRELESS ADAPTER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12540381
• Report Number: 2916596-2021-05654
• Device Sequence Number: 4460924
• Product Code: DSQ
• UDI-Device Identifier: 05415067032065
• UDI-Public: 05415067032065
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 7548852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1