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

Model Number	HMT1100
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that while transitioning off the bypass onto the right ventricular assist device (rvad) and left ventricular assist device (lvad), the heartmate touch would not accept an increase in speed.The customer attempted to increase pump speed by 100rpm but the screen kept processing the input for over 1 minute.The setting button was selected but the drop box did not appear.The patient was switched to a system monitor.The patient was unharmed by the exchange.The patient's lvad was stable and performed as expected.Additional information revealed that the issue with the heartmate touch tablet did not resolve.No other troubleshooting was performed.
Event or Problem Description
Additional information provided stated that the heartmate touch app could not be force-closed due to it being frozen.It was reported that the account switched to the system monitor after the issue was observed.No further issues were reported.
Additional Manufacturer Narrative
Section d6a: date of implant incorrectly provided on previous report.Date of implant is not applicable for heartmate touch kit.Manufacturer's investigation conclusion: the reported event of the heartmate touch app not accepting an increase of speed was not confirmed.The heartmate touch tablet (serial number (b)(6) was returned and evaluated at abbott.The returned heartmate touch tablet was functionally tested with a test wireless adapter, system controller, power module, and mock circulatory loop and was found to function as intended during analysis.The pump speed was changed several times during testing without issue.The system operated for an extended period of time with no issues observed.The reported event could not be reproduced during testing.It was noted during testing that the tablet clock was approximately 188 days behind; this is able to be resolved by setting the clock in the tablet settings and does not indicate an issue with the system.The framework file downloaded from the returned heartmate touch tablet (labeled logheartmateframework_) contained relevant data from the event date of 23aug2022.It should be noted that the framework file captured these events on the timestamp of 16feb2022 due to the tablet clock being approximately 188 days behind.The heartmate touch app was launched on (b)(6) 2022 at 11:07:40.The adapter was connected in the following event at 11:08:05.The heartmate 3 system controller, serial number (b)(6), was connected at 11:08:10.The framework file then captured data consistent with the wireless adapter being disconnected from the power module from 3:11:29 to 3:12:02, and no additional events were captured on the event date.No atypical events were observed in the framework file.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 quality assurance specifications.The heartmate touch kit, serial number (b)(6), was shipped from abbott on 04oct2021.Heartmate 3 instructions for use (ifu), rev.B, chapter 7 ¿alarms and troubleshooting¿ and heartmate touch communication system quick start guide, rev.B, under ¿troubleshooting guide¿ explain how to address the heartmate touch app freezing and how to set the tablet clock if it is incorrect.Heartmate 3 instructions for use (ifu), rev.B, chapter 4, entitled ¿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 use the heartmate touch app.Heartmate touch communication system quick start guide, rev.B, under "quick start" and heartmate 3 instructions for use (ifu), rev.B, chapter 4 ¿heartmate touch communication system¿ state "before launching the heartmate touch app, setup the tablet (in settings) for the specific region, time zone, the language and time format that the tablet is going to be used." no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE TOUCH KIT
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15404957
• Report Number: 2916596-2022-13651
• Device Sequence Number: 14926392
• Product Code: DSQ
• UDI-Device Identifier: 05415067033758
• UDI-Public: 05415067033758
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 8032845
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White