MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number	106128
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the patient having backup battery faults active was confirmed via visual analysis of the returned product and via analysis of the log file.The heartmate 11 volt lithium ion battery (serial number (b)(6)) was returned and evaluated at abbott and a log file was downloaded.The downloaded event log file from the test system controller contained data spanning an unknown amount of time due to the system controller not being set to the correct date and time.The log file captured intermittent atypical backup battery fault alarm active due to a backup battery circuit fault and remained active until the last event.Additionally, the downloaded controller event log file from the returned system controller with the test battery (serial number (b)(6)) contained relevant data spanning approximately 20 minutes on (b)(6) 2023 (8:08 - 8:28).The log file captured intermittent atypical backup battery fault alarm active due to a backup battery circuit fault.The alarm did not affect pump operation while external power was connected to the controller.During the evaluation of the 11v backup battery (serial number: (b)(6), a backup battery fault alarm was active, coincident with a replace backup battery visual indicator active on the controller and system monitor.The controller was disconnected from external power and the backup battery was unable to support the pump.Circuit analysis of the printed circuit board (pcb) revealed that an atypical output voltage was measured coming out of component (integrated circuit (ic) chip) u5, despite having proper input voltage, indicating that the component was not operating as intended.The root cause of the reported event was determined to be an electrically compromised component on the pcb of the battery; however, the root cause of the electronically compromised component could not be determined through this analysis.The heartmate 11 volt lithium ion battery (serial number:(b)(6)) was accepted in storage location on (b)(6) 2023 and inspected per material document.Heartmate 3 instructions for use section 7- ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5- ¿alarms and troubleshooting¿ explain how to troubleshoot the system controller, including backup battery fault alarms.Heartmate 3 patient handbook section 2- "how your heart pump works" explains that the backup battery inside the backup system controller is charged only when the backup system controller is connected to power.It takes up to 3 hours to charge the 11 volt lithium-ion backup battery inside the backup system controller.Heartmate 3 instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate 3 patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment including the system controller power cables and power cable connectors.Heartmate 3 patient handbook and heartmate 3 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.
Event or Problem Description
It was reported that the patient was having consistent external backup battery (ebb) faults.The backup battery was reseated with no resolution of alarms.The system controller was exchanged and the alarms resolved.Related mfr.Report # 2916596-2023-04634.
Additional Manufacturer Narrative
Section d1: corrected section d4, catalog number: corrected section d4, primary udi number: corrected section g4: corrected no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY
• 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: 17870896
• Report Number: 2916596-2023-07188
• Device Sequence Number: 20255406
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(21)SW082350(17)240223(11)220323
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/11/2024

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 Expiration Date: 02/23/2024
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 8417309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White