MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE® POWER MODULE (N/A); VENTRICULAR (ASSIST) BYPASS

Model Number	1340
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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 complete.
Event or Problem Description
It was reported that log files were submitted for review, and it was noted by the site that there would be a no external power event caused by the patient partially disconnecting the power module when pulling on the cable while entering the restroom.The log files captured a no external power alarm and multiple associated alarms on (b)(6) 2025 due to power to the device being briefly interrupted as reported.The patient then switched to battery power and, while doing so, caused a few low power advisory events.The remainder of the log file was unremarkable.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Manufacturer's investigation conclusion: the reported event of a no external power alarm while connected to the power module was confirmed via the submitted log files.Data from the reported event date of 05dec2025 in the submitted controller event log file was reviewed.On 05dec2025 at 09:06:52 while connected to the power module, the no external power alarm activated due to a loss of power.During this event, the bus voltage was observed to have diminished and fluctuate between to 0.1 ¿ 1.6v, compared to the expected 14.5v.This indicates that the no external power alarms occurred despite the controller being connected to an external power source.The backup battery was able to provide power to the controller during this event.The alarm resolved after the patient connected both power cables to batteries.The alarm did not affect the controller's ability to operate the pump at the set speed.There were no other notable alarms active in the log file.The power module was not returned for analysis.The provided information stated that the patient acknowledged that the patient cable became partially disconnected from the power module when they pulled on the cable while entering the restroom.Multiple attempts were made to obtain additional information from the customer regarding the serial number of the unit; however, no response was received.Per the provided information, the root cause for the reported event was due to accidentally disconnecting the power module power cord.Device history records could not be reviewed due to the serial number of the poer module being unavailable.The 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.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 instructions for use rev.D section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook (rev.A) section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot no external power alarms.Heartmate 3 instructions for use rev.D section 2 ¿ ¿system operations¿ explains the operation of the system controller backup battery.This section informs the user that the backup battery is intended only for backup power during a power emergency.The backup battery provides at least 15 minutes of support to the system if the in-use power source is disconnected or fails.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE® POWER MODULE (N/A)
• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23831551
• Report Number: 2916596-2025-08085
• Device Sequence Number: 17410238
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: (01)00813024010654
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2026

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: Lay User/Patient
• Device Model Number: 1340
• Device Catalogue Number: 1340
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/02/2026; 02/20/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/19/2026; 02/24/2026
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 111 KG