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

Model Number	1340
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
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 completed.
Event or Problem Description
It was reported that review of the log files revealed a loss of power to the power module on (b)(6) 2025 was identified.The power module backup battery supported the system as intended during this time.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a loss of external power to the power module (serial number unknown) was confirmed via log file analysis.The submitted log files contained relevant data from the reported event date of 02sep2025.The data reviewed captured the bus and relative state of charge (rsoc) voltages dropping to approximately 12v, which is consistent with the power module being powered by its internal backup battery.The backup battery supported the system as intended.There was no interruption to pump function due to the loss of external power.The power module was not returned for analysis.Provided information indicated that the patient intentionally disconnected their controller from external power.The root cause of the reported event was determined to be user error.The device history records unable to be reviewed due to the serial number of the power module being unknown.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.Section 7 of the ifu entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including no external power alarms.Heartmate 3 patient handbook section 2 entitled ¿how your heart pump works¿ states that the 11v li-ion backup battery inside the system controller can provide enough power to run the pump for at least 15 minutes if the main power source is disconnected.Section 3 of the patient handbook and the ifu, ¿powering the system¿, describes the various ways to power the heartmate 3 lvas.These sections explain how to properly switch between power sources.This section also instructs the user to transfer from the power module (pm) to another power source should there be a power failure.The system controller¿s backup battery will temporarily support the pump while transferring.The patient handbook and ifu caution 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.

• 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: 23910540
• Report Number: 2916596-2025-07999
• Device Sequence Number: 15943759
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/20/2026
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American