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

Model Number	109200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inspection of the power module (pm) revealed a possible acid leak from internal battery and evidence of leak around the battery clamp seeping into the pm.The unit was removed from use and segregated pending examination and repair.
Additional Manufacturer Narrative
Section 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.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a battery leak occurring inside the power module was confirmed.The returned power module (serial number (b)(6), evaluated separately) and the returned sealed lead acid battery (serial number (b)(6) were received at the european distribution center.The battery was observed to have corrosion on its encasing upon arrival, consistent with the battery leaking.The battery was scrapped due to the leakage.The root cause of the observed battery leakage was unable to be conclusively determined through this analysis.The sla battery, serial number (b)(6), was observed to have passed all initial manufacturing testing per the greatbatch manufacturing test datasheet.Using the power module is addressed in instruction for use (ifu) section 3 ¿powering the system/using the power module¿.This section informs the user how to install the backup battery, how to check the charge status of the backup battery and the associated alarms/symbols.Instruction for use (ifu) safety checklists ¿yearly safety checklist¿: schedule a power module inspection and cleaning with company-trained personnel.The inspection and cleaning includes (but is not limited to) functional testing, cleaning, inspection, and replacement of the power module backup battery.Power module precautions and backup power usage are documented in the heartmate power module instructions for use (ifu) : p.3 - precautions and p.33 - pm backup power.The heartmate 3 patient handbook section titled "emergency contact list" cautions 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.The current revision of the patient handbook and instructions for use (ifu) can be found on the eifu page of the abbott website.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: 22152501
• Report Number: 2916596-2025-03478
• Device Sequence Number: 18100060
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/18/2025

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: Health Professional
• Device Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GY253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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