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

Model Number	106762
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was suspected to have a short to shield and was placed on a loaner ungrounded cable.The patient was in rehab when the nursing staff claimed a driveline fault occurred.The 11v battery was reseated and replaced but the alarm did not clear.It was suspected the system controller needed to be exchanged.The left ventricular assist device numbers prior to the exchanged showed the flow to be at 11.4, speed at 9200 rpm, and pulsatility index (pi) and power at 8.7.The driveline was then disconnected and reconnected to the original system controller and the driveline fault alarms cleared immediately.The patient's flow returned to baseline at 5.5 lpm, speed at 9200 rpm, pi at 4.4 and power at 5.7.Upon initial interrogation it was confirmed that the patient had driveline fault alarms where flows were as high as 12, pi was 3.2 and power at the time of the initial alarm was 9.4.The backup system controller was also checked, and it appeared that the clock was not set.The clock was the set, then the single system controller exchange was performed.The transition initially went well, however after approximately 12 seconds the patient stated they didn't feel well and looked pale.The screen showed the speed jumping "all over" between 2499, 7480, 9200.The patient's flow was anywhere from "-.-" to as high as 7.2.It was noted the system controller was alarming at the same time.The patient felt weak and dizzy while on a/c power.Although the patient was unstable, staff exchanged the system controller back to the original system controller that was having driveline fault alarms and was recently connected to batteries.Afterward the patient flows were restored to normal around the 5.4 lpm range.The patient stated during the event they felt like they were going to pass out, like the "light shades were closing".Th system controller, now on battery power, only had two speed alarms, and two driveline disconnect alarms, one which was 56 seconds which was said not the exact case according to staff as they claim they only had them truly disconnected for about 3 seconds.X-rays were taken.Log files were submitted for review and captured short period of driveline fault events on 21nov2025 at 2218 through 22nov2025 at 0107.Pump stop events were also noted on 22nov2025 at 0107 while on the mobile power unit (mpu) and again on 22nov2025 at 0155 while on battery power.It was also noted that the patient was using an older system controller with an older software version v 7.23 which was known to be susceptible to false driveline fault alarms.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a driveline fault alarm on the system controller (serial number: (b)(6)) was confirmed via log file analysis.Data from the reported event date of 21nov2025- 22nov2025 was reviewed in the submitted log file.The log file captured a driveline fault alarm activating due to phase 1 measuring higher than phase 2 and 3; this condition briefly resolved and reactivated several times in the data reviewed.The alarm cleared when the driveline was briefly disconnected from the system controller.The controller was exchanged, but the driveline was reconnected shortly after, consistent with the reported information.The alarm did not prevent the controller from supporting the system as intended while the driveline was connected.The system controller was returned for analysis, and the reported event was not able to be reproduced.No functional issues that would contribute to the driveline fault alarm were noted or observed.Provided information indicated that the cause of the alarms was not able to be identified, and that the system controllers were exchanged, resolving the reported event.The root cause for the reported event was not able to be determined via this investigation.Incidental findings: atypical power cable disconnect alarms due to damaged power cables with evidence of fluid ingress.The device history records were reviewed and found no deviations from manufacturing or qa specifications.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.Heartmate ii instructions for use (rev.C) section 7-¿alarms and troubleshooting¿ and heartmate ii patient handbook (rev.C) section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot all alarms, including driveline fault alarms.Heartmate ii instructions for use (rev.C) section 8-¿equipment storage and care¿ and heartmate ii patient handbook (rev.C) section 6-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER
• 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: 24474814
• Report Number: 2916596-2026-01275
• Device Sequence Number: 13101627
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(17)180731
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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 Expiration Date: 07/31/2018
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• 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: 02/26/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2015
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 139 KG