MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3¿ SYSTEM CONTROLLER LOW FLOW 2.0; VENTRICULAR (ASSIST) BYPASS

Model Number	106531LF2
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
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 the patient had multiple low voltage advisory alarms.The patient had rescue tape on their modular cable near the driveline section due to past exposed wire damage but had not had a modular cable exchange due to their current health status of end stage right ventricular heart failure.They were being treated with iv milrinone and no anticoagulation.Log files were submitted for review.The log file captured numerous odd low power advisories and power cable disconnects while the patient was connected to the mobile power unit (mpu).A loaner mpu was given and used for the past week.Log files were then sent for review on 12aug2025 because the patient continued to have low voltage/ no external power alarms.Per technical services, all of the low power events were due to normal battery depletion.The latest data did not contain any no external power events although there was some odd power cable disconnects.The system controller was a rev 1.5.2 and was around 5 years old.Due to the odd power cable disconnects and the reported damage to the controller white lead, a controller replacement was recommended when/if the patient was able to tolerate a pump stop associated with a controller swap.
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
Additional information received reported that the power cable disconnect alarms on the system controller was due to the patient not making connections properly due to illness.The alarms resolved with family assisting in making the connections.
Additional Manufacturer Narrative
Section h6 correction: medical device problem code 2017 - improper or incorrect procedure or method added, medical device problem code 1171 - disconnection removed.Manufacturer¿s investigation conclusion: the reported event of a power cable disconnect and low voltage alarms was confirmed via the log files.The reported damage to the white power cable could not be confirmed, as no images were submitted, nor was the system controller returned for analysis.The system controller, serial number: (b)(6), event log file was reviewed, and timestamps spanned approximately 1 day (04:22:33 on (b)(6)2025 to 10:23:49 on (b)(6) 2025).Throughout the log file, low power advisory, low power hazard, and power cable disconnect alarms associated with voltage fluctuations were intermittently active.These alarms occurred while connected to battery power or the mobile power unit (mpu) and resolved as the voltages returned to an expected value.There were no remarkable events found within this log file.The pump maintained a speed within the expected range throughout the log file.Additional information stated that the patient was known to have damage to their white power cables; however, the cause for the low voltage and power cable disconnect alarms was stated to be that the patient wasn¿t making the connection properly.The alarms resolved as the family assisted in making connections properly.The root cause of the reported alarms was traced to the user incorrectly connecting their power cables.The root cause of the damage to the white power cable could not be conclusively determined.The relevant sections of the device history records for the heartmate 3 system controller, serial number: (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist device (lvas) instructions for use (ifu), rev.D and the heartmate 3 patient handbook, rev.A are currently available.The current revision of the instructions for use (ifu) can be found on the electronic ifu page of the abbott website.The heartmate 3 lvas ifu (rev.D) section 3 entitled ¿powering the system¿ and the heartmate 3 patient handbook (rev.A) section 3 entitled ¿powering the system¿ address how to properly connect the system controller power cables to the mobile power unit (mpu) patient cable and battery clips.It cautions the user not to misalign the connectors as they may get damaged.It also emphasizes that before connecting power cables, be sure you know how to do it safely and, if you have questions, call your hospital contact.The heartmate 3 lvas ifu (rev.D) section 7 entitled ¿alarms and troubleshooting¿ and the heartmate 3 patient handbook (rev.A) section 5 entitled ¿alarms and troubleshooting¿ address how to properly interpret and troubleshoot all system alarms, including low voltage and power cable disconnect alarms.The heartmate 3 lvas ifu (rev.D) section 8 entitled ¿equipment storage and care¿ and the heartmate 3 patient handbook (rev.A) 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 (rev.A) 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.

• Brand Name: HEARTMATE 3¿ SYSTEM CONTROLLER LOW FLOW 2.0
• 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: 22965402
• Report Number: 2916596-2025-05855
• Device Sequence Number: 9142219
• Product Code: DSQ
• UDI-Device Identifier: 05415067031105
• UDI-Public: (01)05415067031105(17)220906
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/03/2025

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: Lay User/Patient
• Device Expiration Date: 09/06/2022
• Device Model Number: 106531LF2
• Device Catalogue Number: 106531LF2
• Device Lot Number: 7168542
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 09/30/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/18/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White