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

Model Number	109200
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the 12-volt sealed lead acid (sla) battery, serial number (b)(6) , was evaluated due to the reported event of the patient¿s power module appearing unresponsive.This battery was not returned for analysis.Available information for this event indicates that the power module remained unresponsive when battery (b)(6) was connected.However, the cause of the power module appearing unresponsive was isolated to an issue with the power module¿s main printed circuit board, and this issue would have caused sla backup batteries to not function as intended with the unit.The root cause of the reported event has been addressed via the power module¿s investigation, and an sla battery was unable to be correlated to the cause of the event based on the investigation¿s findings.The sla battery, serial number (b)(6) , was observed to have passed all initial manufacturing testing per the greatbatch manufacturing test datasheet.The heartmate 3 patient handbook 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 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.
Event or Problem Description
It was reported that the power module (ppm) was unresponsive to ac power.The unit beeped once when the backup battery was connected.The patient was exchanged to a new ppm backup battery from the hospital and from abbott customer service, neither of which cleared the alarm.The power module was exchanged.It was later reported the replacement backup battery experienced an out of box failure.It was later reported that the loaner ppm lent to the patient by the hospital was returned back to the hospital's inventory where it was verified to be fully functional with other batteries.
Additional Manufacturer Narrative
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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23545679
• Report Number: 2916596-2025-07299
• Device Sequence Number: 18503898
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)270731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/28/2026

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: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GY242
• Was Device Available for Evaluation?: No
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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 Age: 18 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American