MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE; Ventricular (assist) bypass

Model Number	106525US
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was brought to the clinic to download log files and perform a modular cable replacement due to a driveline power fault.The healthcare provider did not attempt to clear the alarm, the last try to clear the alarm was in (b)(6) 2025 which initially silenced the event, but it reoccurred in three hours that then prompted the in-person abbott engineer team to clean the modular cable connection which then cleared the alarm until the date of this event.The healthcare provider then permanently silenced the alarm.There was no obvious external damage to the driveline of the modular cable interface, and the patient was hemodynamically stable.The log file captured new driveline power fault alarms beginning on (b)(6) 2025.The plan was to have the patient transferred to another hospital to clear the alarms and replace the modular cable.There were no other unusual events recorded in the log file event history.Additional log files were submitted that showed on (b)(6) 2025, multiple driveline power faults (pwr b).The modular cable and controller had been replaced to try and resolve the issue, and a replacement was requested.It was additionally communicated that isopropyl alcohol was used to remove debris from the pump side of the connector.The cleaning procedure resolved the driveline power fault b issue.
Additional Manufacturer Narrative
Section d4: device lot number was not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Manufacturer's investigation conclusion: evaluation of the returned heartmate 3 modular cable, as well as review of the submitted images, revealed residue within the inline connector, indicative of oxidation from fluid ingress that would have contributed to the reported driveline power fault alarms.The alarms were confirmed through review of the submitted log files, however the alarms could not be reproduced during evaluation of the returned product.The heartmate 3 modular cable was returned in used condition.The inline connector showed green/gray residue on the pins, which appeared consistent with oxidation due to fluid ingress.A specific source of the residue could not be conclusively determined.The o-rings were properly seated in their respective grooves and appeared unremarkable.The controller connector pins appeared unremarkable.No other signs of damage were observed.The modular cable was tested with a test pump and pump cable on a mock circulatory loop for approximately 1 hour.No alarms were reproduced, even with manipulation of the cable.The modular cable was tested to evaluate the integrity of its wires.The modular cable passed testing without issue.The submitted controller event log file contained events from (b)(6) 2025.A driveline power fault alarm associated with intermittent power b broken faults was active throughout the entirety of the file.The onset of the alarm was not captured.No other notable events or alarms were captured, and the pump appeared to be operating as intended at the stored patient speed.Provided information indicated that the modular cable and system controller were exchanged in an attempt to resolve the alarms, however the alarms persisted.A cleaning of the pump cable inline connector was performed along with a second modular cable exchange, and the driveline power fault alarms resolved (further addressed under the pump investigation).The root cause of the reported event appears consistent with a fluid ingress issue between the pump cable and modular cable connection.A review of the relevant sections of the device history records could not be performed as the serial number of the device was not communicated/identified.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.D, and the heartmate 3 lvas patient handbook, rev.A, are currently available.The current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.Section 7 of the ifu, ¿alarms and troubleshooting¿, and section 5 of the patient handbook, ¿alarms and troubleshooting¿, address system alarms, including driveline power fault alarms, as well as the recommended actions associated with each.Section 8 of the patient handbook, ¿handling emergencies¿, lists examples of emergencies, including driveline power fault alarms, and the recommended actions associated with these emergencies.Furthermore, the patient handbook instructs the user 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.Section 8 of the ifu and section 4 of the patient handbook instruct the user to clean exterior surfaces of the driveline cables with a damp, lint-free cloth and if more aggressive cleaning is needed, to use warm water and mild dish soap.Section 6 of the ifu and section 4 of the patient handbook instruct the user to check the driveline daily for signs of damage, such as cuts, holes, or tears.The patient handbook also states, ¿call your hospital contact right away if the driveline is damaged (or might be damaged)." section 7 of the ifu and section 5 of the patient handbook provide additional instructions regarding driveline care in sub-sections entitled, "what not to do: driveline and cables", which cautions the user not to twist, kink or sharply bend the driveline.Sections 2 and 6 of the ifu and sections 2 and 4 of the patient handbook state that twists, kinks, or sharp bends may cause damage to the wires inside, even if external damage is not visible.These sections further state that if the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
• 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: 24028862
• Report Number: 2916596-2025-07874
• Device Sequence Number: 9357566
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: (01)00813024013181
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: 106525US
• Device Catalogue Number: 106525US
• 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: 12/18/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 13 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White