MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE SYSTEM MONITOR TO POWER MODULE CABLE; VENTRICULAR (ASSIST) BYPASS

Model Number	103859
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cable was not providing power to the system controller.It was later clarified that the black cord was not connecting to the system controller.The mobile power unit and the heartmate monitor to power modular cable were exchanged.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Section a4: patient weight was requested but not provided.Section d4: device serial number and lot number were not provided, and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Manufacturer¿s investigation conclusion: the reported event of the system monitor to power module cable not providing power to the system controller could not be confirmed.The cable was returned in unremarkable physical condition.After visual analysis, the cable was connected to a test system monitor and power module without issue, the system monitor was powered by the cable.The test power module with the returned system monitor to power module cable was connected to a mock loop and left to operate for an extended period.No alarms or issues were observed while test equipment was connected to the returned product.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.No issues were observed during evaluation, and the reported event could not be correlated to an issue with the returned cable.The returned product performed as intended during analysis.No issues were found.The current revision of the instructions for use (ifu) and patient handbook can be found on the electronic ifu page of the abbott website.The heartmate 3 left ventricular assist system ifu, rev.D, heartmate 3 patient handbook, rev.A are currently available.Section 7 of the ifu, entitled ¿alarms and troubleshooting¿, provides instructions on how to interpret and troubleshoot no external power alarms.Section 3 of the ifu, entitled ¿powering the system¿, instructs the user to transfer from the power module (pm) to another power source should there be a power failure.The system controller¿s backup battery will temporarily support the pump while transferring.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE SYSTEM MONITOR TO POWER MODULE 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: 23613899
• Report Number: 2916596-2025-07554
• Device Sequence Number: 21075003
• Product Code: DSQ
• UDI-Device Identifier: 00813024010753
• UDI-Public: (01)00813024010753
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 02/11/2026

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: 103859
• Device Catalogue Number: 103859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 76 YR
• Patient Sex: Male