MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE SYSTEM MONITOR; VENTRICULAR (ASSIST) BYPASS

Model Number	HMT1100
Medical Device Problem Codes	Failure to Power Up (1476); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon asked for pump to be started.The perfusionist went to start the pump and approximately 5 minutes later, the pump was noted to still be off.The perfusionist then started the pump per the surgeon¿s request.The perfusionist swore they turned it on the first time.The historical data was reviewed which showed only 1 pump start in the time frame in question.The ventricular assist device (vad) coordinator sent log files for review and technical services also confirmed there was only 1 pump start.The patient was not affected, and the vad equipment was working appropriately.
Additional Manufacturer Narrative
Section d4: device serial number was not provided, and manufacture date cannot be determined.The primary udi number in d4 is reflective of all available information.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
It was later confirmed that the event occurred on the heartmate touch.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the heartmate touch tablet (serial number: unknown) was evaluated following the reported event of a pump stop during the implant procedure.Log files were submitted for reviewed and could not correlate the reported event with the heartmate touch tablet.The reported event is addressed under the heartmate left ventricular assist device (lvad) investigation.There were no issues found with the heartmate touch.The device history records for the heartmate touch were unable to be reviewed as no product-identifying information was available.The heartmate 3 left ventricular assist device (lvas) instructions for use (ifu) and the heartmate 3 patient handbook are currently available.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The heartmate 3 instructions for use section 8 entitled ¿equipment storage and care¿ and the heartmate 3 patient handbook section 6 entitled ¿caring for the equipment¿ address how to properly care for, maintain, and store the equipment for proper use.The heartmate 3 patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
Further review of the submitted log files revealed that the pump stop event appeared to be the result of the system controller sending a command to disable pump auto-start, per design, due to the pump resetting while the set speed was below 4000 revolutions per minute.

• Brand Name: HEARTMATE SYSTEM MONITOR
• 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: 22340852
• Report Number: 2916596-2025-04009
• Device Sequence Number: 21097412
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2025

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: 06/05/2025
• Supplement Date Received by Manufacturer: Not provided; 10/09/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/31/2025; 10/23/2025
• 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: 33 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White