MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, POWER MODULE PATIENT CABLE 14V; Ventricular (assist) bypass

Model Number	103426
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a low number of events appearing on the history screen was confirmed via the log files.The provided log file correlating to the 14-volt patient cable captured the patient being connected to this patient cable from (b)(6) 2025 ¿ (b)(6) 2025.The voltage values in both of the power cables were observed to be below average while the 14-volt patient cable was in use.These lower values resulted in many intermittent sub-faults associated with the voltage being too low to charge the backup battery.Active alarms did not occur as a result of the lower voltage values or the sub-faults; however, the sub-faults did fill up the log file quickly, and these sub-faults would not be displayed on the system monitor¿s history screen which would cause a lower number of viewable events on the monitor on the given date.The returned 14-volt patient cable (lot number 35050180712) was observed to have a few bent pins in its 16-pin lemo connector upon arrival.The pins were straightened, then the cable was functionally tested, and wire fatigue was observed within most of the cable¿s inner wires.However, the cable was still able to operate alongside a mock loop as intended with no atypical alarms occurring as a result of the fatigue.The root cause of the reported event was determined to correlate to the 14-volt patient cable outputting below-average voltage values, and wire fatigue within the cable, as well as damage to its pins, could contribute to the 14-volt patient cable outputting less voltage than expected.The root causes of the wire fatigue and bent pins were unable to be conclusively determined.The device history records reside with the original equipment manufacturer.The heartmate 3 patient handbook (section 10 ¿safety checklists¿) and the heartmate 3 lvas instructions for use (section f ¿safety checklists¿) instructs users to regularly inspect their equipment, including their patient cables, and to avoid using equipment that appears damaged.Users are encouraged to replace any equipment that appears damaged.The heartmate 3 patient handbook (section titled "emergency contact list") cautions 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 revisions of the patient handbook and instructions for use (ifu) can be found on the eifu page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the log files were submitted for evaluation.The ventricular assist device (vad) coordinator had feedback that all alarms were not being captured and shown on the system monitor.A log files review showed data from (b)(6) 2025 at 4:21:23 to (b)(6) 2025 at 11:01:13.Most of the events were associated with a (f56) v_unable_charge_ebb power fault flags, which was due to worn or damaged patient cable.It was recommended that the patient cable be removed and discarded.It was providing about 12.5 volts to the system controller.This was not enough voltage for the system controller to operate the charging circuitry for the emergency backup battery (ebb).Motor function was not affected by these events.The power fault flags were recordable events but not alarms.The alarm history on the system monitor would not show these events.These events were occurring frequently and was quickly filling up the log file history.The latest log files were provided.The patient cable was exchanged.The event and periodic logs were able to be seen and tallied accordingly.The log files showed the patient cable still delivering less than 13.5 volts.This number should be 14.5 v for a new patient cable.It was recommended anything below 13.5 v be replaced.The patient cable was replaced again.Additional log files showed the voltage had improved and was greater than 14.5 v.The data showed the equipment operating as intended electronically and mechanically.Of note, the 15.6 v that was observed was from the battery which carried a higher voltage than the patient cable.In this case, the battery which was providing 15.6 v on the black power lead and the white power lead of the patient cable would have been 14.7 v.The system controller prioritized sourcing power from a power source with higher voltage and this was the value displayed on the system monitor.Replacing the patient cable resolved the issue.

• Brand Name: HEARTMATE®, POWER MODULE PATIENT CABLE 14V
• 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: 24201341
• Report Number: 2916596-2026-00474
• Device Sequence Number: 5534454
• Product Code: DSQ
• UDI-Device Identifier: 00813024010784
• UDI-Public: (01)00813024010784(10)35050180712(11)120401
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: Health Professional
• Device Model Number: 103426
• Device Catalogue Number: 103426
• Device Lot Number: 35050180712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• 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: 01/16/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2012
• 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 Sex: Unknown