MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION BATTERY CLIP SET; Ventricular (assist) bypass

Model Number	2865
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of damaged o-ring was confirmed with the returned 14v battery clip (lot # 10378361).During functional testing, there was a noted mechanical resistance when mating the test system controller¿s connectors to the battery clip.Visual inspection revealed pieces of the o-ring within the connector and noted what appears to have been fluid/sticky substance.The o-ring was removed.Visual inspection noted the fluid/stick substance and the damage.The fluid/sticky substance was able to be cleaned.The cleaned o-ring was installed into the connector and the noted mechanical resistance issue was resolved.The analysis revealed the fluid/stick substance was creating a mechanical bind and resulted in the connector to be inserted at an angle, which damaged the opposite side of the o-ring.A root cause that led to the fluid/stick substance could not be determined.Device history records reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 instructions for use (rev g) section 3-¿powering the system¿ and heartmate 3 patient handbook (rev g) section 3-¿powering the system¿ addresses how to properly use the 14v battery clip.This section also explains how to properly connect and disconnect the 14v battery from the battery clip.Heartmate 3 instructions for use (rev g) section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook (rev g) section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment, including the battery clips.Additionally, heartmate 3 patient handbook section 10 entitled ¿safety checklists¿, instructs users to regularly inspect their accessories ¿ including their battery clips ¿ for damage, and to replace any equipment that appears damaged or worn.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.
Event or Problem Description
It was reported that the battery clips had a broken o ring.The clips were replaced.

• Brand Name: HEARTMATE®, 14V LI-ION BATTERY CLIP 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: 22128975
• Report Number: 2916596-2025-03467
• Device Sequence Number: 7390393
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: (01)00813024010715(10)10378361(11)240615
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/02/2025

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: 2865
• Device Catalogue Number: 2865
• Device Lot Number: 10378361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• 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: 05/19/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2024
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 86 KG