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

Model Number	HMT1100
Medical Device Problem Codes	Failure to Interrogate (1332); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the log files were provided for the system controller exchange and it was due to a blank screen on the heartmate touch device.After the system controller exchange it looked as though the device was functioning as intended.There were some concerns about blanking flows but the flow looked solid in the limited data provided.It was requested that the log files from the exchanged system controller be provided as it may have more pertinent data.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
After further review of the system controller exchange that was done it was noted the staff was initially unsure why there were dashes for the flow, and education was provided on the heartmate ii with calculating flow.The reason the system controller was changed out was due to the pump running green light being dull and unable to be seen.There was no serial number available for the heartmate touch as the icu has 3 of them.This was said to not be a heartmate touch issue but just an educational issue.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of screen issues on the heartmate touch was unable to be confirmed.It was reported that the heartmate touch displayed dashes for the flow level, causing confusion.The system controller provides an estimate of blood flow out of the pump.This estimate is based on pump speed and power being delivered to the pump motor.This relationship is mostly linear, however, at speeds outside the acceptable linear region, the pump flow displays ¿-.-¿ to prevent the display of inaccurate flow information.Provided information indicated that the serial number of the heartmate touch was unknown, and that the confusion from the dashes displayed for pump flow were the cause of the reported event.No device issues were identified via this investigation.The device history records were unable to be reviewed due to the serial number of the heartmate touch being unknown.Heartmate 3 instructions for use (ifu) (rev.G) chapter 4 ¿heartmate touch communication system¿ and the heartmate touch communication system quick start guide (rev.B) explain the operation of the heartmate touch system, including how to set up the heartmate touch communication system for use.This section also describes the linear relationship between pump power, pump speed, and estimated flow, and explains a flow reading of ¿-.-¿ means.Heartmate 3 instructions for use (ifu) (rev.G) chapter "equipment storage and care" describe how to care for, store, and clean all equipment, including the heartmate touch tablet.Heartmate 3 instructions for use (ifu) (rev.G) chapter 1 "introduction" informs the user to contact abbott for assistance if there are any questions after reading the manual.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: 22301422
• Report Number: 2916596-2025-04171
• Device Sequence Number: 8738392
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2025

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: 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: 05/28/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 09/04/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/21/2025; 09/08/2025
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White