MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 14 VOLT BATTERY CLIP SET; VENTRICULAR (ASSIST) BYPASS

Model Number	2865
Medical Device Problem Codes	Corroded (1131); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented to clinic on (b)(6) 2024, and the batteries and battery clips had corrosion and were replaced along with the universal battery charger (ubc) due to the ubc also having corrosion.Log files were sent for review, noting several low voltage alarms.Additional information was provided that the alarms resolved with the ubc exchange.Related manufacturer reference number: 2916596-2024-01459 (battery); related manufacturer reference number: 2916596-2024-01328 (battery); related manufacturer reference number: 2916596-2024-01458 (universal battery charger).
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 d4: lot number was requested but was unable to be provided.Manufacturer's investigation conclusion: the reported event of atypical low voltage advisory alarms was confirmed via analysis of the submitted log file.The reported event of corrosion on the 14v battery clip was not confirmed.The submitted log file contained approximately 7 days of data ((b)(6) 2024 per the timestamp).The log file captured intermittent low voltage advisory alarms that were not associated with routine battery depletion on (b)(6) 2024 from 05:40:30 to 05:41:31 due to the relative state of charge (rsoc) voltage fluctuating, causing the rsoc voltage to intermittently drop below the low voltage threshold.The atypical alarms occurred while connected to 14v batteries and occurred on the black power lead.The alarms did not affect the controller¿s ability to operate the pump at the set speed.Additional information provided communicated that no products would be returned for analysis.The reported event of corrosion on the 14v battery could have resulted in the atypical low voltage advisory alarms; however, the reported event of corrosion was not confirmed as no products were returned for analysis.The root cause of the reported events could not be conclusively determined through this analysis.The lot number of the 14v battery clip was not reported with the event.Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (auditory and visual), including low voltage advisory alarms, and the actions to take if the issue does not resolve.Heartmate 3 instructions for use section 3 ¿ ¿powering the system¿ and heartmate 3 patient handbook section 3 ¿ ¿powering the system¿ addresses how to properly use the 14v battery.Heartmate 3 patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment, including the 14v battery clip.Additionally, section 10 entitled ¿safety checklists¿ instructs users to regularly inspect their accessories ¿ including their batteries ¿ for damage, 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 14 VOLT 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: 18935492
• Report Number: 2916596-2024-01329
• Device Sequence Number: 17885363
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: 00813024010715
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/29/2024

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
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White