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

Model Number	2465
Medical Device Problem Codes	Corroded (1131); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Section e1: reporter phone number initially reported as (b)(6).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 patient experienced an intermittent noise, which they suspected to have been caused by poor contact.The intermittent noise had been occurring during usage.There were visible signs of corrosion on the metal part of the battery.A replacement was requested.
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 patient experienced an intermittent noise, which they suspected to have been caused by poor contact.The intermittent noise had been occurring during usage.There were visible signs of corrosion on the metal part of the battery.A replacement was requested.It was later reported that the log files were not available.The cause of the corrosion was unknown.The alarm was due to one of the power cables disconnecting.Exchanging the batteries resolved the alarms.It was unknown if the system controller lcd screen displayed the alarms appropriately.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of corroded battery contacts and power cable disconnect alarms was not confirmed.There were photos or log files submitted for review.The 14v li-ion battery, serial (b)(6), was not returned for analysis.The provided information stated that the patient experienced an intermittent noise which was suspected to be caused by poor contact.There were signs of corrosion visible on the battery contacts.Additional information provided stated that there are no log files available from the time of the event, the cause of the corrosion is unknown, a power cable disconnect alarm activated, and exchanging the batteries resolved the alarms.The batteries could not be returned due to the corrosion.A root cause for the reported event was not conclusively determined through this analysis.The 14v battery was inspected and accepted into the storage location on 29oct2024.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 3 instructions for use (ifu) section 3-¿powering the system¿ and heartmate 3 patient handbook section 3-¿powering the system¿ explain how to clean and maintain proper function of the batteries and to check for damage.The ifu states under the weekly safety checklist to clean the metal battery terminals and contacts inside the battery clips and to check for damage.Heartmate 3 patient handbook section 4-¿living with the heartmate 3¿ states that ¿the heartmate 3 system components must be kept dry.Never expose the system controller, batteries, mobile power unit or power base unit to water.If these system components get wet, your pump may stop.Never take tub baths or go swimming while implanted with the pump.The heartmate® gogear® shower bag must be used while showering to keep the system controller and batteries dry.¿ 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: 22982482
• Report Number: 2916596-2025-05798
• Device Sequence Number: 21089509
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)SY289-B152(11)241015
• 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,Followup
• Report Date (Section B): 11/03/2025

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: SY289-B152
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 10/16/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/02/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 67 KG