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

Model Number	2865
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a low voltage advisory alarm.The battery clip was replaced.The patient was symptomatic or injured.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was additionally reported that the patient was not symptomatic or injured.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of low voltage alarm issue could not be confirmed with the returned 14v battery clip (lot # 8488854, 1 of 2).The returned 14v battery clip was unremarkable.Functional testing of the returned product did not reveal any functional issue.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 reported low voltage alarm issue could not be determined through this evaluation.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 patient handbook rev c, 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 voltage advisory alarm.1.Promptly connect to a working or different power source (mobile power unit or two fully-charged heartmate 14 volt lithium-ion batteries).2.If alarm persists, call your hospital contact immediately.For more information, see page 228.No external power alarm.1.Immediately connect the system controller power cables to a working power source (functioning mobile power unit or two fully-charged heartmate 14 volt lithium-ion batteries).2.Call your hospital contact immediately 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 3, powering the system, describes how to use both 14v battery and 14v battery clips.Heartmate 3 instructions for use rev a, under section f, safety checklists, replace any equipment or system component that appears damaged or worn.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: 18803153
• Report Number: 2916596-2024-01275
• Device Sequence Number: 15265960
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: 813024010715
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2865
• Device Lot Number: 8488854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 50 KG