MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP; Ventricular (assist) bypass

Model Number	103696
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: incidental findings: the driveline release button was initially found to be difficult to press, due to debris near the button.The reported event of atypical low voltage alarms was confirmed during review of the submitted and downloaded log files from the returned heartmate ii system controller (serial number: (b)(6).The log files collectively contained approximately 13 days of information (92:16:11 to 105:12:15 in a days: minutes: hours format).Occasionally throughout the data, atypical strings of low voltage advisory alarms were observed.These alarms activated due to the relative state of charge of either power cable briefly fluctuating below the designed alarm threshold.These alarms occurred while the controller was connected to 14v battery power.The low voltage alarms did not impact the ability of the controller to operate the pump at the set speed.During functional testing of the returned controller, atypical alarms were not able to be reproduced.The controller passed all steps of functional testing and was able to support operation of a mock circulatory loop for an extended period of time without issue.The root cause of the low voltage alarms was not able to be conclusively determined through this analysis.During investigation, it was identified that the driveline release button was sticky.The driveline release button was further inspected, and debris was observed.After the button was pressed a few times, the debris was broken up and there were no further issues with the button.The debris was determined to be the cause of the previously observed mechanical resistance.Review of the device history record for the system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications the hmii patient handbook (rev.D) instructs users to regularly inspect their equipment for damage, including the system controller and its power cables, and to obtain replacements if necessary.This document describes how to appropriately respond to all alarm conditions, including low voltage (table 9).The hmii patient handbook also 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
It was reported that the patient experienced multiple pump offs and low voltage alarms.Log files were sent for review, and the data showed speed reduction and pump stopped events on 25jan2025.These issues only appear to be occurring while the ventricular assist device (vad) was connected to power module power.This type of behavior has been linked to potential issues with the percutaneous lead.The patient experienced shortness of breath from the pump offs that was treated with bilevel positive airway pressure (bipap).The patient was being monitored in house, and abbott engineers would perform a driveline repair, as the patient was suspected to have a short to shield.On (b)(6) 2025, tech services arrived onsite for driveline evaluation and repair and performed a driveline repair 2" inches from the exit site.Post repair, the patient was tethered on grounded patient cable without issue.The system controller was exchanged as part of equipment repair.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
• 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: 21609292
• Report Number: 2916596-2025-01870
• Device Sequence Number: 15757514
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: (01)00813024010630(17)220731
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: 07/31/2022
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 7104872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2019
• 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: 133 KG