MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE® SEALED LEAD ACID BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number	109200
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 reporter name: (b)(6).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 a battery error alarmed related to the power module.Red battery symbol lit up.Pictured were submitted for review.The battery was replaced, and the alarm resolved.The defective battery would be returned.
Event or Problem Description
The device was not in use on a patient at the time of the malfunction.
Additional Manufacturer Narrative
A1-a4: there was no patient involved.Section g3: there was no patient involved in this event.The pma# provided is associated with most recent approval.Manufacturer¿s investigation conclusion: the reported event of a red battery alarm was confirmed via analysis of the returned power module backup battery.Upon installing the returned power module backup battery in a known working test power module, a yellow wrench advisory and red battery alarm activated.Ppe evaluation of the returned backup battery revealed that the battery had an unloaded voltage of 11.84 v.The battery was installed in a known working test power module, and upon powering on the system a yellow wrench advisory and red battery alarm activated.The battery was then manually charged to approximately 12.24 v, and the battery was reconnected to the test power module; however, the alarms did not resolve.It was determined that the battery was unable to support the system.Further evaluation was not performed due to the internal chemical hazard.From the additional information, the power module backup battery was replaced, and the unit became fully operational.A root cause for the reported event could not be determined through this analysis.Battery inspection data was reviewed for the 12v sla backup battery, serial number (b)(6), revealing that the battery passed all inspection testing.Heartmate 3 instructions for use (rev.G) section 7 ¿ ¿alarms and troubleshooting¿ and heartmate power module instructions for use (rev.B) under section 5.0 ¿power module (pm) alarm conditions¿ cover all power module alarms and the actions to take when an alarm occurs.Heartmate power module instructions for use (rev.B) under section ¿precautions¿.Section 4.0 ¿power module (pm) backup power¿ describes the usage of the backup battery and the power module visual indicators used to determine the status of the backup battery.Heartmate 3 patient handbook (rev.G) section 6 ¿ ¿caring for the equipment¿ explains how to care for and clean all equipment, including the power module.Additionally, section 10 ¿ ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of the heartmate 3 lvad equipment, including the power module.Heartmate 3 instructions for use (rev.G) section 3 "powering the system" and heartmate power module instructions for use (rev.B) under "introduction" explain how to set up the power module for use, including how to install the power module backup battery, and how to use the power module.The heartmate 3 patient handbook (rev.G) and the heartmate 3 instructions for use (rev.G) 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® SEALED LEAD ACID 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: 20184730
• Report Number: 2916596-2024-05709
• Device Sequence Number: 8850851
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)241231
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 12/31/2024
• Device Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GW012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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 Sex: Unknown