MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET; VENTRICULAR (ASSIST) BYPASS

Model Number	2465
Medical Device Problem Codes	Failure to Charge (1085); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the battery was wet due to leakage from the shower bag.When the battery was attempted to be charged, a red lamp would about about once a week.The shower bag and battery were exchanged.There was no indication that the bag was in inappropriate use at the time, and no damage to the shower bag was found.
Additional Manufacturer Narrative
Section e1: customer site was (b)(6).Manufacturer's investigation conclusion: the reported event of fluid ingress on the 14v li-ion battery (serial number: (b)(6)) was unable to be confirmed.The 14v battery returned in unremarkable physical condition.The battery went through a charge/discharge cycle, was inserted into a test universal battery charger, and was accepted for charge without issue.The battery was functionally tested with a test system controller, 14v battery clip, and mock circulatory loop and was found to operate as intended during analysis the root cause of the reported event was unable to be conclusively determined through this analysis.Battery inspection data was reviewed for the 14v battery, serial number (b)(6), revealing that the battery passed all inspection testing.Heartmate 3 left ventricular assist system (lvas) instructions for use (ifu),and the heartmate 3 patient handbook, are currently available.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 patient handbook section 4 ¿ ¿living with the heartmate 3¿ explains that the heartmate 3 system components, such as the 14v batteries must be kept dry at all times and to never swim or take baths.Section 2 of the ifu, entitled, ¿system operations,¿ states ¿if external system components have contact with water or moisture, the pump may stop.If a heartmate 3 patient is approved for showering, he or she must always use the shower bag during every shower.The shower bag protects external system components from water or moisture.¿ section 8 of the patient handbook ¿ ¿equipment storage and care¿ describe how to care for and clean all equipment, including the 14v batteries.Section 6 of the ifu¿ "patient care and management" explains how to use the shower bag properly with external components including the 14v li-ion battery.Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (visual and auditory), including red light displayed on the universal battery charger and the actions to take if the issue does not resolve.Section 10 of the patient handbook ¿safety checklists¿ instructs users to regularly inspect their equipment, including their 14v li-ion batteries, and to replace any equipment that appears damaged or worn.The patient handbook and the instructions for use caution 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET
• 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: 23761364
• Report Number: 2916596-2025-07654
• Device Sequence Number: 18728304
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)SY157-B151(17)270605
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: SY157-B151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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: 18 YR
• Patient Sex: Male
• Patient Weight: 38 KG