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	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the patients shower bag filling with water and containing the heartmate, 14v li-ion battery clip set was unable to be confirmed.The heartmate, 14v li-ion battery clip set (lot number: 8353121) was not returned for analysis; however, log files were submitted for review.Submitted log files were reviewed, the system controller event log contained data spanning approximately 26 hours (02dec2024 to 03dec2024 per timestamp).The pump operated as intended for the duration of the log files.There were no other notable alarms or events active in the log files.The root cause for the reported event could not be conclusively determined through analysis.The device history records were reviewed for the 14v battery clip set (lot number: 8353121) and found to have passed all manufacturing and qa specifications before being shipped to the customer.Heartmate iii instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate iii patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.Heartmate iii patient handbook section 10 ¿safety checklists¿ provides checklists to assist the patient in performing routine maintenance of heartmate iii lvad, including inspecting all equipment before use.Heartmate iii instructions for use section 6 ¿ ¿patient care and management¿ and heartmate iii patient handbook section 4 ¿ ¿living with the heartmate 3¿ explain how to properly shower utilizing the shower bag to avoid fluid ingress into any component of the system.Heartmate iii patient handbook and heartmate iii instructions for use (ifu) caution 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.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that the patient's shower bag filled with water while they were showering, despite the customer reporting that the shower bag had been used correctly by the patient.The system controller was wet but received the least amount of water due to being at the top of the shower bag.The batteries and battery clips at the bottom of the shower bag were submerged in water.Multiple audible alarms were heard by the patient, which resolved after they dried the equipment, but no alarms were found during their clinic visit, and no further alarms were heard.The patient was asymptomatic throughout the entire event, and no changes were made to the controller.There was no damage to any of the equipment.Event log files were submitted for review and captured routine events despite the water exposure.

• 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: 20918826
• Report Number: 2916596-2024-52462
• Device Sequence Number: 20904423
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: (01)00813024010715(10)8353121(11)220403
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/13/2025

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: 8353121
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2022
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American