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

Model Number	2865
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of atypical intermittent alarm was confirmed via log files.Mdata from 14aug2024 to 15aug2024 was reviewed.The controller event log file revealed atypical low power/power cable disconnect alarm events were captured throughout while both power cables were connected to the 14v batteries/clips.The alarm appears to be active because of transient battery fuel gauge voltage values.The 14v battery clip (lot # 7807622) was returned and visual inspection revealed corrosion on the metal contacts.The 14v battery clip was tested together with the returned system controller (serial # (b)(6), and the atypical low power/power cable disconnect alarm captured in the log file could not be reproduced.A test battery was installed into the battery clip with no noticeable mechanical resistance.The system operated solely on each test battery/battery clip with an expected power cable disconnect alarm when the test 14v battery was disconnected.A root cause of the atypical low power/power cable disconnect alarm captured in the log file could not be determined through this evaluation.Heartmate 3 patient handbook rev d, cautions the users to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 5, ¿alarms and troubleshooting¿, all alarm conditions are addressed.This includes ¿connect power¿ alarms.Low power alarm 1.Promptly connect to a working or different power source (mobile power unit or two heartmate batteries).2.Call your hospital contact if connecting to power does not resolve the alarm.Power cable disconnect alarm 1.Promptly connect the disconnected power cable to a working power source (mobile power unit or two fully-charged heartmate batteries).2.Call your hospital contact if reconnecting the power cable does not resolve the alarm.Under section 2, ¿the system controller self test¿, the system controller self test is loud and bright.All of the lights, symbols, and sounds come on and ¿self test¿ appears on the screen.Heartmate 3 instructions for use rev c, under section f, safety checklists, replace any equipment or system component that appears damaged or worn.Inspect all cables for signs of damage.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that patient was having intermittent alarms, and the battery clips were exchanged since they were not recognizing fully charged batteries attached.

• 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: 20604093
• Report Number: 2916596-2024-07258
• Device Sequence Number: 7929467
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: (01)00813024010715(10)7807622(11)210205
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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
• Device Catalogue Number: 2865
• Device Lot Number: 7807622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• 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: 10/31/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Race: White